Drugs / Tramadol
Tramadol
also known as
Tramadol Hydrochloride · Tramadol HCL · Tramal · Ultram · Tramadol Contramid OAD · TRAM · Trama · tramadol ER · +35 more
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | acute pain | 2020-10-12 | “received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the Company’s New Drug Application (“NDA”) for IV tramadol.” avenuetx.com ↗ |
| Filed | US (FDA) | — | acute pain | 2019-12-11 | “the Company’s resubmission of its NDA for IV tramadol was a complete, class 1 response to the Complete Response Letter (“CRL”) dated October 9, 2020” avenuetx.com ↗ “today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IV tramadol” avenuetx.com ↗ |
| Label expansion | US (FDA) | TRAMADOL HYDROCHLORIDE | — | 2011-09-20 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | ULTRAM | — | 1998-08-21 – 1999-12-23 | fda.gov ↗ |
| Approved | US (FDA) | ULTRAM | — | 1995-03-03 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT06561672 | Sep 2024 → Mar 2025 overdue | — | Zagazig University | Enrolling by invitation | No outcome recorded |
| Phase 0 | NCT05756504 | Feb 2023 → Jan 2024 | acute pancreatitis | Hayatabad Medical Complex | Unknown | No outcome recorded |
| Phase 0 | NCT05614440 | May 2012 → Nov 2013 | — | Marmara University | Completed | No outcome recorded |
| Phase 121 trials | ||||||
| Phase 1 | NCT07032558 | Sep 2025 overdue | — | Haiphong University of Medicine and Pharmacy | Recruiting | No outcome recorded |
| Phase 1 | NCT07060209 | Sep → Oct 2025 overdue | — | Haiphong University of Medicine and Pharmacy | Recruiting | No outcome recorded |
| Phase 1 | NCT05925686 | Jun → Oct 2023 | — | Parc de Salut Mar | Completed | No outcome recorded |
| Phase 1 | NCT04375865 | May → Jul 2020 | — | Addpharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03767036 | Jun 2017 | — | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 1 | NCT03766984 | Jun 2015 | — | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 1 | NCT02307864 | Dec 2014 → Aug 2015 | — | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01947920 | Aug → Nov 2013 | — | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01606059 | May → Jun 2012 | — | Daewon Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01880125 | Jan → May 2012 | — | Yungjin Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01800682 | Jul → Sep 2011 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT00772967 | Jun → Nov 2008 | osteoarthritis | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 1 | NCT00973232 | May → Aug 2008 | — | Labopharm Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01586494 | Oct 2007 → Jun 2009 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT01586507 | Oct 2007 → Sep 2008 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00487175 | Sep → Dec 2007 | — | University Hospital, Clermont-Ferrand | Completed | No outcome recorded |
| Phase 1 | NCT00834912 | Feb → Apr 2006 | — | Labopharm Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00834366 | Feb → Mar 2005 | — | Labopharm Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00911742 | Feb → Mar 2004 | — | Labopharm Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00834808 | Nov → Dec 2002 | — | Labopharm Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00653315 | May → Aug 2002 | — | Par Pharmaceutical, Inc. | Completed | No outcome recorded |
| Phase 1/26 trials · 1 missed | ||||||
| Phase 1/2 | NCT04454307 | Jul → Aug 2020 | COVID-19 | Tanta University | Unknown | No outcome recorded |
| Phase 1/2 | NCT03121547 | May 2015 → Jan 2016 | drug-induced dyskinesia | Frederiksberg University Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT01188421 | Oct 2010 → Jun 2015 | opiate dependence | Johns Hopkins University | Completed | Missed primary |
| Phase 1/2 | NCT01178203 | Jul 2010 | pulpitis | Azad University of Medical Sciences | Completed | No outcome recorded |
| Phase 1/2 | NCT00301210 | Jan 2006 → Oct 2007 | substance-related disorder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1/2 | NCT00111046 | Feb 2001 → Feb 2004 | malignant choroid melanoma | Royal Liverpool University Hospital | Unknown | No outcome recorded |
| Phase 215 trials · 1 met primary | ||||||
| Phase 2 | NCT06345716 | Apr 2024 → Mar 2025 overdue | urinary tract obstruction | University of Monastir | Recruiting | No outcome recorded |
| Phase 2 | NCT05616364 | Mar 2023 → Mar 2024 | benign shuddering attacks | Sana Bahadur | Unknown | No outcome recorded |
| Phase 2 | NCT04752384 | Jul 2021 → Apr 2024 | head and neck squamous cell carcinoma | Medical College of Wisconsin | Completed | No outcome recorded |
| Phase 2 | NCT05463367 | Jan 2021 → Jun 2025 overdue | chronic pain syndrome, opiate dependence, substance abuse | Northwestern University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03850587 | Aug 2018 → May 2020 | osteoarthritis, knee | Yooyoung Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02999594 | Dec 2016 → Apr 2018 | — | Maulana Azad Medical College | Unknown | No outcome recorded |
| Phase 2 | NCT02014363 | Oct 2013 → Oct 2015 | major depressive disorder | e-Therapeutics PLC | Completed | No outcome recorded |
| Phase 2 | NCT02247648 | Jun 2013 → Dec 2017 | — | University of Montreal Hospital Centre (CHUM) | Terminated | No outcome recorded |
| Phase 2 | NCT01552096 | Dec 2011 → Oct 2013 | inflammatory disease | Imam Abdulrahman Bin Faisal University | Completed | No outcome recorded |
| Phase 2 | NCT01307020 | Feb → Oct 2011 | — | Menarini Group | Completed | Met primary |
| Phase 2 | NCT01630343 | Jan 2010 → Apr 2012 | — | Queen Elizabeth Hospital, Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT00752661 | Jun → Nov 2007 | osteoarthritis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT00952068 | Jan → Apr 2007 | — | Labopharm Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00333346 | Sep 2006 → Apr 2009 | — | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 2 | NCT00142896 | Feb → Dec 2005 | opiate dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06735443 | Mar 2021 → Apr 2022 | hernia, double inguinal | Sahiwal medical college sahiwal | Completed | No outcome recorded |
| Phase 2/3 | NCT00980044 | Oct 2009 → Feb 2012 | substance withdrawal syndrome | Michelle Lofwall | Completed | No outcome recorded |
| Phase 338 trials · 10 met primary · 1 missed | ||||||
| Phase 3 | NCT05928520 | Aug 2023 → Sep 2024 | — | Al-Azhar University | Unknown | No outcome recorded |
| Phase 3 | NCT07469826 | Oct 2022 → Apr 2023 | — | Jinnah Postgraduate Medical Centre | Completed | No outcome recorded |
| Phase 3 | NCT05324059 | Jul 2022 → Apr 2023 | neuropathy, painful | Laboratorios Silanes S.A. de C.V. | Completed | No outcome recorded |
| Phase 3 | NCT07043049 | Jun → Dec 2022 | benign shuddering attacks | Syed Muhammad Abbas | Completed | No outcome recorded |
| Phase 3 | NCT05390905 | Jun → Dec 2022 | — | Haisco Pharmaceutical Group Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT05311722 | Apr → Dec 2022 | — | Sheikh Zayed Medical College | Unknown | No outcome recorded |
| Phase 3 | NCT05362851 | Nov 2021 → Jan 2023 | osteoarthritis, knee | Yooyoung Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04312061 | Mar → Jul 2020 | — | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT03678792 | Nov 2019 → Sep 2020 | opiate dependence, substance withdrawal syndrome | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 3 | NCT03586934 | Jun 2018 → Jun 2019 | substance-related disorder | Rush University Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03395808 | Dec 2017 → Apr 2019 | — | Avenue Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03714672 | Aug 2017 → Mar 2018 | — | Grünenthal GmbH | Completed | Met primary |
| Phase 3 | NCT03062644 | Apr 2017 → Jun 2018 | — | Mundipharma Research GmbH & Co KG | Completed | Missed primary |
| Phase 3 | NCT01904149 | May 2013 → May 2014 | — | Menarini Group | Completed | Met primary |
| Phase 3 | NCT01902134 | Apr 2013 → Feb 2014 | — | Menarini Group | Completed | Met primary |
| Phase 3 | NCT02658721 | Jan → Jun 2013 | — | Bagcilar Training and Research Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01889979 | Oct 2012 → May 2013 | — | Saint Thomas Hospital, Panama | Completed | No outcome recorded |
| Phase 3 | NCT00983736 | Oct 2009 → Sep 2010 | premature ejaculation | Bausch Health Americas, Inc. | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT01476774 | Aug 2009 → Jun 2010 | intervertebral disk degenerative disorder | Mundipharma (China) Pharmaceutical Co. Ltd | Completed | Met primary |
| Phase 3 | NCT00983151 | Aug 2009 → Sep 2010 | premature ejaculation | Bausch Health Americas, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01112267 | May → Oct 2009 | — | Janssen Korea, Ltd., Korea | Completed | Met primary |
| Phase 3 | NCT03365817 | Feb 2009 → Dec 2014 | chronic pain syndrome, substance-related disorder | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 3 | NCT00736853 | Jun 2008 → Jan 2009 | — | Janssen Pharmaceutical K.K. | Completed | Met primary |
| Phase 3 | NCT00736957 | May 2008 → Oct 2009 | chronic pain syndrome | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT00737048 | Mar → Sep 2008 | — | Janssen Pharmaceutical K.K. | Completed | Met primary |
| Phase 3 | NCT00713726 | Jan 2006 → Jul 2008 | — | Federal University of São Paulo | Completed | No outcome recorded |
| Phase 3 | NCT00833794 | Oct 2004 → Jan 2006 | osteoarthritis | Labopharm Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00236535 | Dec 2003 → Oct 2004 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00210847 | Dec 2003 → May 2005 | diabetic polyneuropathy | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 3 | NCT00833911 | Apr 2003 → Jul 2004 | osteoarthritis, knee | Labopharm Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00852917 | Jan → Aug 2003 | — | Labopharm Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00832416 | Jan → Aug 2003 | osteoarthritis, knee | Labopharm Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00348452 | Sep 2002 → Aug 2003 | chronic pain syndrome | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00912015 | Mar 2002 → Jul 2003 | osteoarthritis, knee | Labopharm Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00325858 | Jan 2002 → Dec 2003 | chronic pain syndrome | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00348010 | Nov 2000 → Jul 2001 | chronic pain syndrome | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00347724 | Nov 2000 → Nov 2001 | chronic pain syndrome | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00347685 | Oct 2000 → Feb 2003 | chronic pain syndrome | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 462 trials · 5 met primary · 3 missed | ||||||
| Phase 4 | NCT07826988 | Oct 2026 → Oct 2029 expected | sickle cell disease | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07840183 | Sep 2026 → Sep 2027 expected | — | Northwestern University | Recruiting | No outcome recorded |
| Phase 4 | NCT07796152 | Sep 2026 → Dec 2027 expected | — | Endeavor Health | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07064993 | Jul 2026 → Feb 2027 expected | — | Arzu Esen Tekeli | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07440069 | Feb → Aug 2026 overdue | — | Universidad Nacional Autonoma de Honduras | Recruiting | No outcome recorded |
| Phase 4 | NCT07113782 | Nov 2024 → Apr 2025 | benign prostatic hyperplasia | Armed Forces Institute of Urology, Rawalpindi | Completed | No outcome recorded |
| Phase 4 | NCT06612996 | Oct 2024 → Jan 2025 overdue | ulcer of lower limbs, varicose disease | Al-Azhar University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06495632 | Aug 2024 → Jul 2026 overdue | — | Cape Fear Valley Health System | Recruiting | No outcome recorded |
| Phase 4 | NCT06076707 | Nov 2023 → May 2024 | — | Wollo University | Unknown | No outcome recorded |
| Phase 4 | NCT06113497 | Nov 2023 → Oct 2024 | — | Kyunghee University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT05825560 | May 2023 → Jun 2026 | — | Nîmes University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05657704 | Oct 2022 → Dec 2023 | — | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Unknown | No outcome recorded |
| Phase 4 | NCT04391855 | May 2022 → Nov 2024 | neuropathy, painful, spinal cord disorder, spinal stenosis | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
| Phase 4 | NCT06231043 | Apr 2022 → Mar 2023 | — | Lampang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05237492 | Jan 2022 → Jul 2023 | blood coagulation disease, platelet disorder, undefined, poisoning | Medical University of Graz | Completed | No outcome recorded |
| Phase 4 | NCT05183334 | Dec 2021 → Dec 2022 | premature ejaculation | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT04991493 | Sep 2021 → Nov 2023 | — | Affiliated Cancer Hospital of Shantou University Medical College | Unknown | Missed primary |
| Phase 4 | NCT05488925 | Jun 2021 → Feb 2022 | pulpitis | Farjad Zafar | Completed | Met primary |
| Phase 4 | NCT04551833 | Apr 2021 → Apr 2023 | — | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT03809442 | Jun 2019 → Aug 2023 | — | Aga Khan University | Completed | No outcome recorded |
| Phase 4 | NCT04835116 | Apr → Oct 2019 | — | Armed Forces Institute of Urology, Rawalpindi | Completed | No outcome recorded |
| Phase 4 | NCT03781544 | Jan 2019 → Jul 2025 | osteoarthritis | University of Zurich | Unknown | No outcome recorded |
| Phase 4 | NCT03694873 | Oct → Dec 2018 | — | Cairo University | Unknown | No outcome recorded |
| Phase 4 | NCT03509740 | Apr → Oct 2018 | primary dysmenorrhea | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT03469310 | Mar 2018 → Dec 2019 | goiter, parathyroid gland adenoma, parathyroid hyperplasia, thyroid cancer | Minerva A Romero Arenas | Completed | No outcome recorded |
| Phase 4 | NCT03477851 | Jun 2017 → Jun 2020 | bone disorder | Medical University of Warsaw | Completed | No outcome recorded |
| Phase 4 | NCT03622489 | Mar 2017 → Aug 2018 | — | Wolfson Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02958566 | Jan → Dec 2017 | colon carcinoma, constipation disorder, diverticulitis of colon, paralytic ileus +1 | University of Illinois College of Medicine at Peoria | Unknown | No outcome recorded |
| Phase 4 | NCT02777970 | Apr 2016 → Feb 2017 | — | Menarini Group | Completed | Met primary |
| Phase 4 | NCT02964416 | Mar 2016 → Mar 2018 | brain neoplasm | Aga Khan University | Completed | No outcome recorded |
| Phase 4 | NCT02851394 | Oct 2015 → May 2016 | — | Centre Hospitalier Universitaire Dijon | Completed | Missed primary |
| Phase 4 | NCT02595190 | Mar 2015 → Mar 2020 | pain agnosia | Southwest Hospital, China | Unknown | No outcome recorded |
| Phase 4 | NCT02110966 | Apr → Oct 2014 | pulpitis | Daniel Chavarría Bolaños | Completed | No outcome recorded |
| Phase 4 | NCT01916915 | Jul 2013 → Feb 2016 | neuropathy, painful | Ufuk University | Completed | No outcome recorded |
| Phase 4 | NCT01943760 | Sep 2012 → Sep 2013 | — | Federal University of São Paulo | Completed | No outcome recorded |
| Phase 4 | NCT01517711 | Sep 2011 → Aug 2014 | post-traumatic stress disorder | INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium | Completed | Missed primary |
| Phase 4 | NCT01416116 | Jul 2011 → Apr 2012 | peripheral nerve lesion, postherpetic neuralgia | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT01782846 | Mar 2011 → Feb 2013 | — | Hopital Foch | Completed | No outcome recorded |
| Phase 4 | NCT01345162 | Mar 2010 → May 2012 | — | Fondazione IRCCS Policlinico San Matteo di Pavia | Completed | No outcome recorded |
| Phase 4 | NCT00766675 | Oct 2008 → Mar 2009 | fibromyalgia | Johnson & Johnson Taiwan Ltd | Completed | No outcome recorded |
| Phase 4 | NCT00766402 | Sep 2008 → Feb 2009 | ankylosing spondylitis | Johnson & Johnson Taiwan Ltd | Terminated | No outcome recorded |
| Phase 4 | NCT00785603 | Aug 2008 | depressive disorder | University of Southern Denmark | Unknown | No outcome recorded |
| Phase 4 | NCT02246712 | Jun 2008 → May 2010 | neuropathy, painful, type 1 diabetes mellitus, type 2 diabetes mellitus | São Paulo State University | Completed | No outcome recorded |
| Phase 4 | NCT00735748 | Mar 2008 → Jun 2009 | — | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT00647517 | Mar 2008 → Jul 2009 | ankylosing spondylitis | Chung Shan Medical University | Completed | No outcome recorded |
| Phase 4 | NCT01019265 | Mar 2008 → Mar 2009 | osteoarthritis | Mundipharma Korea Ltd | Completed | No outcome recorded |
| Phase 4 | NCT00692263 | Feb → Aug 2008 | — | University of Southern Denmark | Completed | No outcome recorded |
| Phase 4 | NCT00560443 | Feb 2008 → Apr 2012 | — | IRCCS Burlo Garofolo | Completed | No outcome recorded |
| Phase 4 | NCT01728246 | Oct 2007 → May 2008 | osteoarthritis | Janssen Pharmaceutica | Completed | Met primary |
| Phase 4 | NCT01843660 | Sep 2007 → May 2008 | — | Xian-Janssen Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00635349 | May 2007 → Apr 2009 | osteoarthritis | Janssen Korea, Ltd., Korea | Completed | No outcome recorded |
| Phase 4 | NCT00519246 | Feb → Dec 2007 | neuropathy, painful | Nanjing Medical University | Completed | No outcome recorded |
| Phase 4 | NCT00510666 | Jan → May 2007 | — | Nanjing Medical University | Completed | No outcome recorded |
| Phase 4 | NCT00634543 | Dec 2006 → Oct 2008 | diabetic neuropathy | Janssen Korea, Ltd., Korea | Completed | No outcome recorded |
| Phase 4 | NCT00310908 | Sep 2006 → Feb 2009 | nephrolithiasis | Hadassah Medical Organization | Completed | No outcome recorded |
| Phase 4 | NCT00290901 | Mar → Dec 2006 | — | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00576173 | Dec 2005 → Feb 2007 | — | Johnson & Johnson Taiwan Ltd | Completed | No outcome recorded |
| Phase 4 | NCT01063842 | Aug 2005 → May 2006 | osteoarthritis | Janssen Korea, Ltd., Korea | Completed | No outcome recorded |
| Phase 4 | NCT00210561 | Mar → Apr 2005 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT00297375 | Apr → Aug 2003 | migraine disorder | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 4 | NCT00236483 | Nov 2002 → Feb 2003 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 4 | NCT00246168 | ? → Jun 2005 | rheumatoid arthritis | Janssen Korea, Ltd., Korea | Completed | No outcome recorded |
| Phase not applicable31 trials · 2 met primary · 2 missed | ||||||
| — | NCT07852104 | Sep 2026 → Dec 2027 expected | — | Aydin Adnan Menderes University | Not yet recruiting | No outcome recorded |
| — | NCT07610408 | Jun → Sep 2026 | — | Ankara Etlik City Hospital | Completed | No outcome recorded |
| — | NCT06860100 | Nov 2025 → Jun 2026 overdue | hemorrhoid | Yuzuncu Yil University | Active not recruiting | No outcome recorded |
| — | NCT07264309 | Nov 2025 → Dec 2026 expected | — | Zohar Nachum | Recruiting | No outcome recorded |
| — | NCT07036237 | Mar → Nov 2025 overdue | — | Dow University of Health Sciences | Enrolling by invitation | No outcome recorded |
| — | NCT07386288 | Nov 2024 → Apr 2025 | — | Ataturk University | Completed | No outcome recorded |
| — | NCT07838662 | Oct 2024 → Oct 2025 | — | Punjab Rangers Teaching Hospital Lahore | Completed | No outcome recorded |
| — | NCT06240390 | May → Aug 2024 | neuropathy, painful | Universidad Europea de Canarias | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT06608056 | Jan → Jun 2024 | — | Pakistan Air Force (PAF) Hospital Islamabad | Completed | No outcome recorded |
| — | NCT06112223 | Apr → Sep 2023 | — | Tanta University | Completed | No outcome recorded |
| — | NCT05538052 | Apr → Nov 2022 | pulpitis | Jamia Millia Islamia | Completed | No outcome recorded |
| — | NCT05311774 | Apr 2022 → Oct 2025 | — | Assiut University | Completed | No outcome recorded |
| — | NCT05905757 | Mar 2022 → Mar 2023 | — | Yuzuncu Yil University | Completed | Missed primary |
| — | NCT06642480 | Jan 2022 → Mar 2023 | — | National Research and Innovation Agency | Completed | No outcome recorded |
| — | NCT03532841 | May → Aug 2018 | — | Cairo University | Unknown | No outcome recorded |
| — | NCT04176783 | Mar 2018 → Jul 2021 | — | OrthoCarolina Research Institute, Inc. | Completed | No outcome recorded |
| — | NCT03934411 | Mar 2018 → Mar 2019 | substance-related disorder | University of Copenhagen | Completed | No outcome recorded |
| — | NCT04037878 | Nov 2017 → Jun 2020 | — | Aga Khan University | Completed | No outcome recorded |
| — | NCT03054220 | Jul 2016 → Dec 2018 | — | Jules Desmeules | Completed | No outcome recorded |
| — | NCT03693222 | May → Nov 2016 | — | Bakirkoy Dr. Dr. Sadi Konuk Research and Training Hospital | Completed | No outcome recorded |
| — | NCT02971540 | Feb 2016 → Jul 2017 | lumbar disk disease | Medical University of Silesia | Completed | No outcome recorded |
| — | NCT02440399 | Jul 2015 → May 2017 | — | HaEmek Medical Center, Israel | Completed | Missed primary |
| — | NCT03260439 | Jun → Dec 2014 | — | Leila mansali stambouli | Completed | No outcome recorded |
| — | NCT02012244 | Jan → Dec 2014 | colorectal cancer | Severance Hospital | Completed | No outcome recorded |
| — | NCT02750696 | Apr 2013 → Dec 2014 | suppurative periapical periodontitis | Federal University of Rio Grande do Sul | Completed | No outcome recorded |
| — | NCT01764048 | Nov 2012 → Jan 2014 | — | HaEmek Medical Center, Israel | Completed | No outcome recorded |
| — | NCT01227200 | Nov 2011 | peritonsillar abscess | HaEmek Medical Center, Israel | Unknown | No outcome recorded |
| — | NCT05831761 | Sep 2009 → Oct 2011 | — | University Medical Centre Ljubljana | Completed | Met primary |
| — | NCT00610155 | Sep 2008 → Jul 2010 | — | Viatris Inc. | Completed | No outcome recorded |
| — | NCT00386243 | Dec 2007 → May 2012 | chronic pain syndrome | VA Office of Research and Development | Completed | Met primary |
| — | NCT00361686 | Jan 2006 → Jan 2007 | — | Rabin Medical Center | Completed | No outcome recorded |
| Comparator or background therapy222 trials | ||||||
| Phase 0 | NCT07204379 Comparator | Jan → Jul 2023 | — | Armed Forces Institute of Dentistry, Pakistan | Completed | No outcome recorded |
| Phase 1 | NCT05256108 Comparator | Mar → Jul 2022 | substance abuse | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05533073 Comparator | Aug → Sep 2020 | — | Laboratorios Silanes S.A. de C.V. | Completed | No outcome recorded |
| Phase 1 | NCT05389150 Comparator | Jan → Feb 2019 | — | Laboratorios Silanes S.A. de C.V. | Completed | No outcome recorded |
| Phase 1 | NCT03775629 Comparator | Dec 2018 → Apr 2019 | — | CrystalGenomics, Inc. | Completed | No outcome recorded |
| Show all 222 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2022-09-22 | Avenue Therapeutics, Inc. | Regulatory Avenue Therapeutics Announces Reverse Stock Split and Provides Regulatory Update for IV Tramadol Including Receipt of Type A Meeting Minutes from the FDA avenuetx.com ↗ |
| 2021-11-29 | Avenue Therapeutics, Inc. | Regulatory Avenue Therapeutics Announces FDA Advisory Committee Meeting to Review IV Tramadol NDA Tentatively Scheduled for February 15, 2022 avenuetx.com ↗ |
| 2021-10-25 | Avenue Therapeutics, Inc. | Regulatory Avenue Therapeutics Receives Interim Response to its Formal Dispute Resolution Request from U.S. Food and Drug Administration Office of New Drugs avenuetx.com ↗
Accordingly, the FDA will convene an Advisory Committee meeting and seek advice from the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. |
| 2021-06-14 | Avenue Therapeutics, Inc. | Regulatory Avenue Therapeutics Receives Complete Response Letter from the FDA for IV Tramadol avenuetx.com ↗
Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced that it has received a second Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its New Drug Application (“NDA”) seeking approval for IV tramadol. |
| 2020-12-18 | Avenue Therapeutics, Inc. | Results Avenue Therapeutics Announces Publication of Tramadol Non-Medical Use in Four European Countries: A Comparative Analysis avenuetx.com ↗
Despite high availability, tramadol has a low rate of misuse and abuse in the four countries. |
| 2020-12-18 | Avenue Therapeutics, Inc. | Results Avenue Therapeutics Announces Publication of Real-World Data on Nonmedical Use of Tramadol in ASI-MV Network avenuetx.com ↗
Compared to other common opioid compounds, tramadol had significantly lower rates of NMU, non-oral routes of administration such as snorting or injecting, and diversion, suggesting a lower abuse potential. |
| 2020-10-12 | Avenue Therapeutics, Inc. | Regulatory Avenue Therapeutics Receives Complete Response Letter from the FDA for IV Tramadol avenuetx.com ↗
Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced it has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the Company’s New Drug Application (“NDA”) for IV tramadol. |
| 2020-07-21 | Avenue Therapeutics, Inc. | Results Avenue Therapeutics Announces Publication of Phase 3 Bunionectomy Study Results avenuetx.com ↗
The study established a clear dose response, with IV tramadol 50 mg demonstrating a statistically significant benefit (p < 0.05) over placebo for primary and all key secondary efficacy endpoints, whereas IV tramadol 25 mg demonstrated intermediate results between the 50 mg and placebo arms. |
| 2020-06-05 | Avenue Therapeutics, Inc. | Results Avenue Therapeutics Announces Publications in Peer-Reviewed Journals avenuetx.com ↗
The results of the study demonstrated that IV tramadol was statistically superior to placebo and comparable to IV morphine for the primary and all key secondary efficacy outcomes. |
| 2020-04-23 | Avenue Therapeutics, Inc. | Results Avenue Therapeutics Announces Presentation of IV Tramadol E-Posters avenuetx.com ↗
IV tramadol 50 mg was statistically significantly superior to placebo for the primary efficacy endpoint and all three key secondary efficacy endpoints. |
| 2020-02-13 | Avenue Therapeutics, Inc. | Regulatory Avenue Therapeutics Announces New Drug Application for IV Tramadol Accepted for Review by FDA avenuetx.com ↗
“The NDA submission acceptance is another important step toward bringing IV tramadol to patients and their healthcare providers in the U.S.,” said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer. |
| 2019-12-11 | Avenue Therapeutics, Inc. | Regulatory Avenue Therapeutics Announces Submission of New Drug Application for IV Tramadol avenuetx.com ↗ |
| 2019-10-28 | Avenue Therapeutics, Inc. | Results Avenue Therapeutics Announces Publication of IV Tramadol Phase 1 Clinical Data in Clinical Pharmacology in Drug Development avenuetx.com ↗
The IV tramadol 50 mg dosing regimen was well tolerated, with adverse event profiles consistent with the known pharmacological effects of tramadol. |
| 2019-06-03 | Avenue Therapeutics, Inc. | Results Avenue Therapeutics Announces Positive Topline Data from Second Pivotal Phase 3 Study of Intravenous Tramadol in the Management of Postoperative Pain avenuetx.com ↗
Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a specialty pharmaceutical company focused on the development and commercialization of intravenous (IV) tramadol, today announced that its second pivotal Phase 3 trial of IV tramadol achieved the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 24 hours (SPID24) compared to placebo in patients with postoperative pain following abdominoplasty surgery. |
| 2018-05-21 | Avenue Therapeutics, Inc. | Results Avenue Therapeutics Announces Positive Topline Phase 3 Data for Intravenous Tramadol in the Management of Postoperative Pain avenuetx.com ↗
In addition, the trial met its key secondary endpoints and demonstrated a clear dose response. |
| 2011-12-09 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA approval for generic Ultram® ER tablets sunpharma.com ↗
Sun Pharma announces USFDA approval for generic Ultram® ER Tablets |
| 2010-07-23 | Nippon Shinyaku Co., Ltd. | Regulatory がん疼痛治療剤「トラマール®カプセル25mg」「同50mg」の製造販売承認取得のお知らせ nippon-shinyaku.co.jp ↗
日本新薬は、がん疼痛治療剤「トラマール®カプセル25mg」「同50mg」（一般名：トラマドール塩酸塩）について、2010年7月23日付で製造販売承認を取得しましたのでお知らせいたします。 |
| 2002-06-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Tramadol HCl Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval of the company's ANDA for Tramadol Hydrochloride Tablets, 50 mg. |
| 2002-01-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approvable Status of ANDA for Tramadol HCl Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has granted "approvable" status for Tramadol Hydrochloride Tablets, 50 mg. |
All press releases naming this drug 34 releases
Evidence & citations 47 cited values
Every value below carries the sentence it was read from. 413 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tramadol | “The purpose of this study is to compare the pharmacokinetic (PK) of single oral doses of ULTRAM Extended Release (ER) at 2 dose levels in adolescents between 12 and 17 years...” NCT01586507 ↗368“Eligible patients were randomized (1:1) to receive low-dose 7-day BTDS (5, 10, and 20 μg/h, maximum dosage of 20 μg/h) or sustained-release tramadol tablets (100 mg, maximum...” PMID 25503600 ↗ Jul 2015 “All patients will be submitted to the institution's standard management: multimodal analgesia with common analgesic (dipyrone 4 to 8 g / day or paracetamol 1500 to 2250 mg /...” NCT07666178 ↗ “400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA (patient-controlled analgesia): 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval,...” NCT05474014 ↗ “Purpose: pharmacokinetic interactions and safety of AD-2111 and AD-2112 in healthy adult volunteers Condition or disease : Pain Intervention/treatment Drug : AD-2111(Celecoxib...” NCT04375865 ↗ “Opioid standard care pain medicine prescribed for an outpatient total knee arthroplasty is typically hydrocodone/acetaminophen (Norco), oxycodone (Oxycontin), or tramadol...” NCT07796152 ↗ “Afterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and...” NCT05943015 ↗ “initially receiving nefopam and tramadol, implementing with ketamine if patients remain painful, and then implementing with remifentanil with escalating doses in case of...” PMID 39832962 ↗ Jan 2025 “A patient controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and...” NCT05630404 ↗ “Nonsteroidal anti-inflammatory drug celecoxib (200 mg on request, up to two times daily)27 and tramadol (100 mg on request, up to 400mg daily) will be available for as-needed analgesia.” NCT06344403 ↗ “Intravenous paracetamol 1 gr and a dose of 0,5 mg/kg-1 tramadol intravenously will be performed on all patients 30 min before the end of the surgery for postoperative analgesia.” NCT05621161 ↗ |
| Known as | AD-2112 | “Purpose: pharmacokinetic interactions and safety of AD-2111 and AD-2112 in healthy adult volunteers Condition or disease : Pain Intervention/treatment Drug : AD-2111(Celecoxib...” NCT04375865 ↗ |
| Known as | contramal | “patients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy.” NCT03204708 ↗ |
| Known as | ETS6103 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02014363 ↗ |
| Known as | Extended Release Tramadol | “Extended Release Tramadol (Tramadol ER)” NCT00347724 ↗ |
| Known as | TA-ER | “OBJECTIVE: To evaluate the relative efficacy and safety of extended-release tramadol HCl 75 mg/acetaminophen 650 mg (TA-ER) and immediate-release tramadol HCl...” PMID 25299350 ↗ Oct 2014 |
| Known as | TA-IR | “OBJECTIVE: To evaluate the relative efficacy and safety of extended-release tramadol HCl 75 mg/acetaminophen 650 mg (TA-ER) and immediate-release tramadol HCl...” PMID 25299350 ↗ Oct 2014 |
| Known as | Tradonal Odis | “Tramadol per os (Tradonal Odis® orodispersible tablets)” NCT00735748 ↗ |
| Known as | TRAM | “Since JNS013 is a combination of tramadol hydrochloride (TRAM) acting as a weak opioid with acetaminophen (APAP) inhibiting central COX-3” NCT00752661 ↗2“fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM)” NCT01902134 ↗ “tramadol hydrochloride (TRAM)” NCT00736957 ↗ |
| Known as | Tram (Tradol) | “Tram (Tradol®)” NCT05389150 ↗ |
| Known as | Trama | “Women will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally 2 hours before IUD insertion.” NCT02827487 ↗2“Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to Celecoxib” NCT02736019 ↗ “Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally” NCT03585036 ↗ |
| Known as | Trama SR | “Group I who will receive Tramadol 100mg (Trama SR®, Global Napi) orally 1 hour before the procedure, group II who will receive Celecoxib 200mg (Celebrex® 200, Pfizer) 1 hour...” NCT02071303 ↗1“Group I who will receive Tramadol 100mg (Trama SR®, Global Napi) orally 1 hour before the procedure” NCT02419651 ↗ |
| Known as | Tramadol 100 MG/ML | “Tramadol 100 MG/ML” NCT03785041 ↗ |
| Known as | Tramadol 50 MG/ML | “Tramadol 50 MG/ML” NCT03785041 ↗ |
| Known as | Tramadol BID | “A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol OAD Tablets to Twice Daily Tramadol BID for the Treatment of Osteoarthritis of the Knee (Extension...” NCT00912015 ↗ |
| Known as | Tramadol Contramid OAD | “A three-way crossover study in 27 human volunteers was conducted to characterize
the pharmacokinetics and to assess the dose proportionality of 100 mg, 200 mg
and 300 mg...” PMID 17575561 ↗ Sep 20075“CONCLUSIONS: The results of this exploratory study suggest that similar to immediate-release tramadol, onset of analgesia for this controlled-release formulation of tramadol...” PMID 19070266 ↗ Sep 2008 “This placebo-controlled study examined the analgesic efficacy, safety, and clinical benefit of Tramadol Contramid OAD, a once-daily formulation with both immediate- and...” PMID 18181382 ↗ Sep 2007 “An open-label phase was followed by a double-blind phase, in which a total of 646 patients were randomized to double-blind treatment with placebo or Tramadol Contramid OAD.” PMID 17583466 ↗ Jun 2007 “two Tramadol Contramid® OAD 300 mg controlled-release tablets from two different manufacturing sites” NCT00834912 ↗ “once-daily formulation of tramadol (Tramadol Contramid OAD 200-mg tablets)” PMID 20051587 ↗ Jan 2010 |
| Known as | Tramadol Contramid once-a-day | “The primary objective of this study is to determine the time of onset of analgesic effect of Tramadol Contramid® Once-A-Day (OAD) in acute low back pain.” NCT00952068 ↗ |
| Known as | Tramadol Contramid once-daily | “The aim of this study was to compare the pharmacokinetic profile and oral bioavailability of Tramadol Contramid once-daily (o.d.) 200 mg tablets (Labopharm, Canada) with that...” PMID 16894407 ↗ Jul 2006 |
| Known as | tramadol ER | “A 7-day taper using clonidine (n = 36), tramadol ER (n = 36), or buprenorphine (n = 31) was then instituted, and patients were crossed-over to double-blind placebo during a...” PMID 28700791 ↗ Sep 20172“Open-label Assessment of the Safety and Effectiveness of Extended Release Tramadol (Tramadol ER) in the Treatment of Chronic Non-malignant Pain.” NCT00347685 ↗ “Extended Release Tramadol (Tramadol ER)” NCT00347724 ↗ |
| Known as | Tramadol HC1 IR | “Some participants will receive a medication approved by the Food and Drug Administration for treatment of moderate to moderately severe pain called Tramadol HC1 IR.” NCT01598753 ↗ |
| Known as | Tramadol HCL | “Participants will receive 1 tablet containing 75 mg of tramadol HCl and 650 mg of acetaminophen, once daily on Days 1to 3, then 1 tablet twice daily on Days 4 to 7” NCT01112267 ↗15“The reference treatment consists of two separate controlled-release film-coated tablets: Pelubi CR (Pelubiprofen 45 mg) and Zytram CR (Tramadol HCl 75 mg).” NCT07032558 ↗ “Cases were assessed as intravenous opioid with 1 mg/kg tramadol HCl (Group O, n=20) or ultrasonography-guided quadratus lumborum block (Group B, n=20).” NCT03693222 ↗ “A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis” NCT00833794 ↗ “the test product, Tramadol HCl Once-A-Day (OAD) 200 mg tablets and the reference product, Tramadol HCl 50 mg (IR) tablets (Ortho-McNeil Ultram®).” NCT00834288 ↗ “Patients will be equally assigned to receive a total dose of either tramadol HCl 75 mg/acetaminophen 650 mg or tramadol HCl 100 mg or placebo.” NCT00236483 ↗ “Patients will receive infusion of Tramadol HCl (Tramosel®) via patient-controlled analgesia system (Gemstar®)” NCT02824770 ↗ “Tramadol HCL. Dosage form: Injection Strength: 50mg/ampoule Frequency: 1 time” NCT01887951 ↗ “DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl)” NCT00973232 ↗ “Group II:received IV 2 mg/kg tramadol HCL.” NCT02449954 ↗ “Tramadol HCl, 50 mg” NCT01947920 ↗ |
| Known as | Tramadol HCl ER | “The purpose of this study is to compare the analgesic efficacy and safety of tramadol HCl ER 100 mg, 200 mg and 300 mg once a day (QD), with placebo in patients with moderate...” NCT00348452 ↗2“Extended-release Tramadol Hydrochloride(Tramadol HCl ER)100 Mg, 200 Mg, 300 Mg, And 400 Mg With Placebo” NCT00325858 ↗ “Extended Release Tramadol Hydrochloride (Tramadol HCl ER)” NCT00348010 ↗ |
| Known as | Tramadol HCl ODT | “The purpose of this clinical trial is to test an experimental drug therapy called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol HCl ODT" or the...” NCT00983736 ↗1“The purpose of this clinical trial is to test an experimental drug therapy called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol HCl ODT" or the...” NCT00983151 ↗ |
| Known as | Tramadol HCl/Acetaminophen ER | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01814878 ↗ |
| Known as | Tramadol HCl/Acetaminophen IR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01814878 ↗ |
| Known as | Tramadol Hydrochloride | “Tramadol hydrochloride, a synthetic opioid is an orally active, clinically effective centrally acting analgesic having a lower incidence of respiratory depression, cardiac...” NCT02071303 ↗49“A Randomized, Double-blind, Multi-site, Comparator-controlled, Phase III Trial to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Tramadol Hydrochloride and...” NCT03714672 ↗ “The combination of tramadol hydrochloride and acetaminophen in an extended-release formulation has been shown to provide rapid and long-lasting analgesic effects resulting from...” PMID 24183364 ↗ Oct 2013 “A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in...” NCT00983736 ↗ “The purpose of this clinical trial is to test an experimental drug therapy called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol HCl ODT" or the...” NCT00983151 ↗ “Tramadol hydrochloride, a centrally acting, synthetic analgesic, has been available in Europe since 1977 in a variety of formulations and in the United States since 1995.” PMID 19070266 ↗ Sep 2008 “Extended Release Tramadol Hydrochloride (Tramadol HCl ER) 100 mg, 200 mg, 300 mg, Celecoxib 200 mg and Placebo in the Treatment of Osteoarthritis of the Knee and/or Hip.” NCT00348452 ↗ “DW-1021 is a novel fixed-dose combination salt formulation containing pelubiprofen 45 mg and tramadol hydrochloride 45.9 mg (equivalent to 40.3 mg tramadol free base).” PMID 41821212 ↗ Mar 2026 “Tramadol hydrochloride is a synthetic analog of codeine that acts on both opioid (weak m receptor agonist) and nonopioid receptors” NCT04391855 ↗ “Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams” NCT01764048 ↗ “Tramadol hydrochloride, a synthetic opioid is an orally active, clinically effective centrally acting analgesic” NCT02419651 ↗ |
| Known as | Tramadol Hydrochloride (HCl) | “The purpose of this study is to determine the safety and tolerability profile of tramadol hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages...” NCT01947920 ↗1“1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fasting condition.” NCT00834912 ↗ |
| Known as | tramadol hydrochloride extended-release (ER) | “OBJECTIVE: To evaluate whether tramadol hydrochloride extended-release (ER), an approved analgesic with opioid and nonopioid mechanisms of action and low abuse potential, is...” PMID 28700791 ↗ Sep 2017 |
| Known as | Tramadol OAD | “A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol OAD Tablets to Twice Daily Tramadol BID for the Treatment of Osteoarthritis of the Knee (Extension...” NCT00912015 ↗1“The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit of Tramadol OAD tablets versus Placebo.” NCT00833794 ↗ |
| Known as | tramadol ODT | “Subjects were randomized to receive 1:1:1 placebo (n=200), 62 mg tramadol ODT (n=206), or 89 mg tramadol ODT (n=198).” PMID 21889833 ↗ Aug 2011 |
| Known as | Tramadol Once A Day | “One Tramadol Once A Day tablet at randomized dose daily.” NCT00832416 ↗1“Drug: Tramadol Once a day” NCT00833794 ↗ |
| Known as | Tramadol Once-A-Day (OAD) | “The purpose of this study is to evaluate the long-term safety (up to one year) of Tramadol Once-A-Day (OAD) tablets at the highest doses: 200-400 mg” NCT00912015 ↗ |
| Known as | tramadol retard actavis | “The subjects will orally ingest 100 mg tramadol retard actavis” NCT03934411 ↗ |
| Known as | Tramadolhydrochlorid | “Tapentadol (Palexia Depot), and Tramadolhydrochlorid (Mandolgin Retard)” NCT03121547 ↗ |
| Known as | Tramal | “Patients in group Tramadol will intravenously administrate dose of 1 mg/kg/8hr tramal to be increased upon patient needs up to 2mg/kg/6hr as rescue analgesic” NCT04613830 ↗6“an oral tramadol tablet (Tramal®, Memphis, Giza, Egypt) 1 h before the procedure” NCT03701984 ↗ “The control group routinely injected tramadol 100mg(Tramal) intramuscularly” NCT07066111 ↗ “Tramadol 50mg (Tramal ®, Memphis,) orally 1 hour before the procedure” NCT02425709 ↗ “an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet” NCT03532841 ↗ “Drug: Tramal®” NCT04647435 ↗ |
| Known as | Tramal drops | “Tramadol hydrochloride (Tramal drops, Laboratoire, Grunenthal, Aachen-Germany) would be given.” NCT02355678 ↗ |
| Known as | Tramal retard | “Initial dose of oral tramadol (depottabl Tramal retard, Orionpharma, Finland) will be 100mg once daily.” NCT01116531 ↗ |
| Known as | Tramaw | “one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.” NCT03694873 ↗ |
| Known as | Tramosel | “Patients will receive infusion of Tramadol HCl (Tramosel®) via patient-controlled analgesia system (Gemstar®)” NCT02824770 ↗ |
| Known as | Tridol SR | “tramadol (Tridol® SR (slow release) Tablet 100mg)” NCT01019265 ↗ |
| Known as | Tridol SR tab | “TramadolSR tab (Tridol SR tab)” NCT01019265 ↗ |
| Known as | Ultram | “The purpose of this study is to compare the safety, pharmacokinetic properties (the absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets),...” NCT02205554 ↗6“Opioid standard care pain medicine prescribed for an outpatient total knee arthroplasty is typically hydrocodone/acetaminophen (Norco), oxycodone (Oxycontin), or tramadol...” NCT07796152 ↗ “This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.” NCT00290901 ↗ “the test product, Tramadol HCl Once-A-Day (OAD) 200 mg tablets and the reference product, Tramadol HCl 50 mg (IR) tablets (Ortho-McNeil Ultram®).” NCT00834288 ↗ “IV Tramadol \[Ultram\] introduced when needed after surgery” NCT06112548 ↗ “50 mg tramadol (1x50 mg Ultram tablet)” NCT03312777 ↗ “Tramadol (Ultram®)” NCT06240390 ↗ |
| Known as | Zertane | “To assess the safety of tramadol orally disintegrating tablet (ODT) (Zertane) and its efficacy in prolonging intravaginal ejaculation latency time (IELT) and improving...” PMID 21889833 ↗ Aug 2011 |
| Known as | Zytram CR | “The reference treatment consists of two separate controlled-release film-coated tablets: Pelubi CR (Pelubiprofen 45 mg) and Zytram CR (Tramadol HCl 75 mg).” NCT07032558 ↗ |
| Action | Inhibit | “Its mechanism of action involves weak binding to the mu-opioid receptors and inhibition of reuptake of both norepinephrine and serotonin.” PMID 18052769 ↗ Dec 2007 |
| Modality | Small molecule | “centrally acting opioid pain killer” NCT01558622 ↗ |
| Route | Oral | “oral tramadol” NCT00111046 ↗ |