Drugs / Lactulose
Lactulose
also known as
Duphalac · Duphalac (r) · Duphlac, lactulose · Kristalose · LAC · Lactofiltrum · Lactulose Oral Solution · Laevolac
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CEPHULAC | — | 1980-06-27 | fda.gov ↗ |
| Approved | US (FDA) | CEPHULAC | — | 1976-03-25 | fda.gov ↗ |
Trials 49 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01256541 | Dec 2010 → Sep 2011 | — | Benaroya Research Institute | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07354100 | Dec 2026 → Apr 2029 expected | cancer | University of Chicago | Recruiting | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT02123017 | Apr → Aug 2014 | — | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01887470 | Jul → Oct 2013 | — | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02017119 | Jan 2011 → May 2014 | cirrhosis of liver, hepatic encephalopathy | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Completed | No outcome recorded |
| Phase 2 | NCT00616876 | Feb 2005 → Aug 2006 | infectious disease with sepsis, necrotizing enterocolitis | Bnai Zion Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00403858 | Oct 2000 → Apr 2002 | intestinal impaction | Norgine | Completed | No outcome recorded |
| Phase 2 | NCT00404040 | Oct 2000 → Jul 2002 | constipation disorder | Norgine | Completed | No outcome recorded |
| Phase 2 | NCT00004796 | Nov 1994 → Feb 1997 | cirrhosis of liver, hepatic encephalopathy, portal hypertension | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT06835361 | Feb 2024 → Sep 2025 overdue | vulvovaginal candidiasis | AVVA Pharmaceuticals Ltd. | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05061992 | Nov 2021 → Nov 2022 | cirrhosis of liver | University of Michigan | Completed | No outcome recorded |
| Phase 2/3 | NCT01089348 | Jul → Oct 2010 | bacterial vaginosis | Avva Rus, JSC | Unknown | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05794555 | Jun 2023 → Mar 2025 | cirrhosis of liver, portal hypertension | University of Michigan | Completed | No outcome recorded |
| Phase 3 | NCT05076799 | Sep 2021 → Nov 2022 | — | Sichuan University | Completed | No outcome recorded |
| Phase 3 | NCT02086825 | Oct 2015 → Dec 2016 | hepatic encephalopathy | NYU Langone Health | Withdrawn | No outcome recorded |
| Phase 3 | NCT01607060 | Sep 2008 → Apr 2012 | constipation disorder | Federal University of São Paulo | Completed | No outcome recorded |
| Phase 3 | NCT00553423 | Nov 2007 → Nov 2008 | hepatic encephalopathy | Aga Khan University | Unknown | No outcome recorded |
| Phase 3 | NCT00364689 | Aug 2006 → Jul 2008 | hepatic encephalopathy | University of Miami | Terminated | No outcome recorded |
| Phase 414 trials | ||||||
| Phase 4 | NCT07060222 | Sep 2025 → Nov 2026 expected | — | Hospital Civil de Guadalajara | Recruiting | No outcome recorded |
| Phase 4 | NCT06748638 | Sep 2024 → Oct 2025 overdue | — | Haifeng Lan | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06666556 | Jul 2024 → Jul 2025 overdue | colorectal cancer | Hospital Civil de Guadalajara | Recruiting | No outcome recorded |
| Phase 4 | NCT05788627 | Apr → Sep 2023 | hepatic encephalopathy, liver disorder | Khyber Medical College, Peshawar | Unknown | No outcome recorded |
| Phase 4 | NCT05687409 | Nov 2019 → May 2021 | cirrhosis of liver, metagonimiasis | First Affiliated Hospital of Zhejiang University | Completed | No outcome recorded |
| Phase 4 | NCT03666546 | Nov 2018 → Mar 2019 | type 2 diabetes mellitus | Fresenius Kabi | Completed | No outcome recorded |
| Phase 4 | NCT02158182 | Jul 2014 → Jun 2016 | hepatic encephalopathy | Hospital General de Mexico | Completed | No outcome recorded |
| Phase 4 | NCT01842581 | Jan 2013 → Dec 2014 | cirrhosis of liver, hepatic encephalopathy | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00712543 | Jun → Sep 2009 | constipation disorder | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00748904 | Jun 2008 → Jul 2009 | cirrhosis of liver, kidney failure | Weill Medical College of Cornell University | Withdrawn | No outcome recorded |
| Phase 4 | NCT01175538 | Jan 2008 → Jun 2010 | hepatic encephalopathy | Govind Ballabh Pant Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00375375 | Jan → Dec 2004 | hepatic encephalopathy | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| Phase 4 | NCT00160264 | Jan 2003 → ? | osteoporosis | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00160290 | Mar 2002 → Jun 2006 | hemorrhoid | Solvay Pharmaceuticals | Terminated | No outcome recorded |
| Phase not applicable17 trials | ||||||
| — | NCT07589465 | Jun 2026 → Jun 2029 expected | appendicitis, functional gastric disease, ileus | Nanchong Central Hospital | Recruiting | No outcome recorded |
| — | NCT07084350 | Aug 2025 → Jan 2026 overdue | type 2 diabetes mellitus | General Hospital of Shenyang Military Region | Not yet recruiting | No outcome recorded |
| — | NCT06808009 | Feb 2025 → Feb 2026 overdue | liver failure | Institute of Liver and Biliary Sciences, India | Not yet recruiting | No outcome recorded |
| — | NCT05878639 | Mar → Jul 2023 | inflammatory bowel disease | Second Affiliated Hospital of Wenzhou Medical University | Completed | No outcome recorded |
| — | NCT05726344 | Feb → Dec 2023 | — | Hospital de Clínicas Dr. Manuel Quintela | Completed | No outcome recorded |
| — | NCT05498714 | Jul 2022 → Jun 2023 | — | Renmin Hospital of Wuhan University | Unknown | No outcome recorded |
| — | NCT05648318 | Jan → Sep 2022 | colonic neoplasm | Zhang Xiaofeng,MD | Completed | No outcome recorded |
| — | NCT04794049 | May → Oct 2021 | colonic disorder | First People's Hospital of Hangzhou | Unknown | No outcome recorded |
| — | NCT04582942 | Aug 2020 → Aug 2021 | — | Renmin Hospital of Wuhan University | Completed | No outcome recorded |
| — | NCT06082622 | Mar 2016 → Apr 2019 | constipation disorder | Minia University | Completed | No outcome recorded |
| — | NCT02397512 | Feb → Oct 2015 | — | University of Zurich | Completed | No outcome recorded |
| — | NCT01923376 | Feb 2013 → Feb 2014 | cirrhosis of liver, hepatic encephalopathy | New York Presbyterian Brooklyn Methodist Hospital | Withdrawn | No outcome recorded |
| — | NCT01295138 | Feb 2011 → Feb 2012 | constipation disorder | NHS Fife | Unknown | No outcome recorded |
| — | NCT01283152 | Jan 2011 → Jun 2012 | cirrhosis of liver, hepatic encephalopathy | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| — | NCT01231828 | Sep 2009 → Jun 2012 | cirrhosis of liver | University Hospital, Caen | Completed | No outcome recorded |
| — | NCT00914056 | Sep 2008 → May 2009 | hepatic encephalopathy | Hunter Holmes Mcguire Veteran Affairs Medical Center | Completed | No outcome recorded |
| — | NCT00273949 | Jan 2006 → Jan 2007 | nosocomial infection | Bnai Zion Medical Center | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 57 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT07683936 Background | Jun 2026 → Jan 2027 expected | hepatic encephalopathy | Air Force Military Medical University, China | Recruiting | No outcome recorded |
| Phase 0 | NCT05279586 Comparator | Mar 2022 → Feb 2023 | hepatic encephalopathy | Madonna Magdy Fahmy | Unknown | No outcome recorded |
| Phase 0 | NCT03962998 Comparator | Oct 2019 → Oct 2021 | small bowel Crohn disease | MediBeacon | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT05700695 Background | Jan 2023 → Jun 2025 | hepatic encephalopathy, liver disorder | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| Phase 1 | NCT04238416 Background | Nov 2019 → Dec 2021 | hepatic encephalopathy, liver disorder | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| Phase 1 | NCT00829777 Background | Mar → Sep 2009 | opiate dependence | California Pacific Medical Center Research Institute | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07648394 Comparator | Aug → Dec 2026 expected | anus disorder, constipation disorder | China-Japan Friendship Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07454408 Background | Mar 2026 → Jun 2028 expected | hepatic encephalopathy | Air Force Military Medical University, China | Not yet recruiting | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT02334163 Background | Dec 2014 → Feb 2015 | hepatic encephalopathy | Ain Shams University | Unknown | No outcome recorded |
| Phase 2 | NCT00811434 Comparator | Jan 2009 → Nov 2010 | hepatic encephalopathy | Indiana University | Terminated | No outcome recorded |
| Phase 2 | NCT00508482 Comparator | Apr 2008 → Sep 2011 | constipation disorder | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00558038 Comparator | Sep 2007 → Mar 2009 | hepatic encephalopathy | Ocera Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00001337 Background | May 1993 → May 2024 | Burkitt lymphoma, anaplastic large cell lymphoma, mediastinal gray zone lymphoma, primary mediastinal large B-cell lymphoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2/36 trials | ||||||
| Phase 2/3 | NCT05341180 Comparator | May 2022 → Jul 2023 | constipation disorder | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Phase 2/3 | NCT03420144 Comparator | Jan 2018 → Jun 2020 | cirrhosis of liver | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| Phase 2/3 | NCT03415698 Comparator | Jul 2016 → Jul 2018 | cirrhosis of liver | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 2/3 | NCT02464124 Background | Jan 2016 → Dec 2017 | hepatic encephalopathy | Tanta University | Unknown | No outcome recorded |
| Phase 2/3 | NCT01124318 Comparator | May → Sep 2010 | atopic eczema | Avva Rus, JSC | Completed | No outcome recorded |
| Phase 2/3 | NCT01008293 Comparator | Oct 2009 → Jun 2012 | hepatic encephalopathy, liver disorder | CD Pharma India Pvt. Ltd. | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07534995 Comparator | May 2026 → Dec 2027 expected | opioid-induced constipation | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05754996 Background | Mar 2023 → Jul 2025 | hepatic encephalopathy | Cairo University | Completed | No outcome recorded |
| Phase 3 | NCT06411314 Comparator | Dec 2022 → Jul 2023 | vulvovaginal candidiasis | Avva Rus, JSC | Completed | No outcome recorded |
| Phase 3 | NCT04128462 Background | Nov 2021 → Apr 2025 | hepatic encephalopathy | Mallinckrodt | Withdrawn | No outcome recorded |
| Phase 3 | NCT03957668 Comparator | Dec 2019 → Sep 2020 | constipation disorder | Faculty of Medicine, University of Indonesia | Unknown | No outcome recorded |
| Phase 3 | NCT00745147 Comparator | Jul 2008 → Oct 2009 | constipation disorder | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00255372 Comparator | Apr 2005 → May 2008 | constipation disorder | Ipsen | Completed | No outcome recorded |
| Phase 416 trials | ||||||
| Phase 4 | NCT06538077 Background | Feb 2025 → Aug 2026 overdue | cirrhosis of liver, hepatic encephalopathy | Post Graduate Institute of Medical Education and Research, Chandigarh | Recruiting | No outcome recorded |
| Phase 4 | NCT07037394 Comparator | Dec 2024 → Apr 2025 | hepatic encephalopathy | Qurratul Ain Jamil | Completed | No outcome recorded |
| Phase 4 | NCT05920213 Background | Oct 2023 → Apr 2024 | hepatic encephalopathy | Jinnah Postgraduate Medical Centre | Unknown | No outcome recorded |
| Phase 4 | NCT05134584 Comparator | Jan → Dec 2021 | dyspepsia, irritable bowel syndrome | RenJi Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04436601 Comparator | Mar 2020 → Dec 2023 | hepatic encephalopathy | Aga Khan University | Unknown | No outcome recorded |
| Phase 4 | NCT04073290 Comparator | Jan 2020 → Sep 2026 expected | cirrhosis of liver, hepatic encephalopathy, portal hypertension | Academic Medical Center - University of Amsterdam | Recruiting | No outcome recorded |
| Phase 4 | NCT04243681 Comparator | Jul 2019 → Aug 2020 | cirrhosis of liver | Asian Institute of Gastroenterology, India | Completed | No outcome recorded |
| Phase 4 | NCT03833999 Background | Oct 2018 → Jun 2019 | intestinal motility disease | University of Nottingham | Completed | No outcome recorded |
| Phase 4 | NCT03987893 Background | May 2018 → May 2020 | hepatic encephalopathy, liver disorder | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 4 | NCT03148002 Comparator | Jul 2017 → Apr 2018 | constipation disorder | Nova Scotia Health Authority | Completed | No outcome recorded |
| Phase 4 | NCT03100513 Comparator | Mar 2017 → Oct 2019 | hepatic encephalopathy | Tanta University | Unknown | No outcome recorded |
| Phase 4 | NCT03177434 Comparator | Feb 2016 → May 2018 | constipation disorder | Children's Memorial Health Institute, Poland | Unknown | No outcome recorded |
| Phase 4 | NCT02228616 Background | Oct 2014 → Sep 2016 | constipation disorder | Xian-Janssen Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT01842113 Comparator | Apr 2013 → May 2014 | cirrhosis of liver, hepatic encephalopathy, portal hypertension | Tampa General Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT00740142 Comparator | Sep 2008 → Aug 2010 | hepatic encephalopathy | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT01178372 Comparator | Sep 2008 → Sep 2010 | hepatic encephalopathy | Govind Ballabh Pant Hospital | Unknown | No outcome recorded |
| Phase not applicable15 trials | ||||||
| — | NCT07273734 Background | Jan 2026 → Jun 2027 expected | hepatic encephalopathy | West China Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06483737 Background | Jun 2025 → Jun 2027 expected | hepatic encephalopathy | General Hospital of Shenyang Military Region | Recruiting | No outcome recorded |
| — | NCT07002827 Background | Jun 2025 → Dec 2026 expected | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Recruiting | No outcome recorded |
| — | NCT06802042 Comparator | Jan → Dec 2025 overdue | constipation disorder | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| — | NCT04013113 Background | Jul 2019 → Jul 2020 | liver disorder | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT03115697 Comparator | Apr 2018 → Apr 2019 | hepatic encephalopathy | Institute of Liver and Biliary Sciences, India | Withdrawn | No outcome recorded |
| — | NCT03448770 Comparator | Aug 2017 → Jul 2018 | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT03161106 Comparator | May 2017 → Oct 2018 | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Withdrawn | No outcome recorded |
| — | NCT04787276 Comparator | Jan 2017 → Jan 2020 | cirrhosis of liver, hepatic encephalopathy, liver failure | Bogomolets National Medical University | Completed | No outcome recorded |
| — | NCT02321371 Background | Oct 2014 → Jan 2016 | liver disorder | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT02255747 Comparator | Sep 2014 → Aug 2016 | constipation disorder | Tongji Hospital | Unknown | No outcome recorded |
| — | NCT02265484 Background | Nov 2013 → Jan 2015 | parkinsonian disorder | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT01773538 Comparator | Jan 2013 → Oct 2015 | cirrhosis of liver, hepatic encephalopathy | Mette Munk Lauridsen | Completed | No outcome recorded |
| — | NCT01446523 Comparator | Oct 2011 → Feb 2012 | hepatic encephalopathy | Govind Ballabh Pant Hospital | Completed | No outcome recorded |
| — | NCT01218568 Comparator | Oct 2010 → Sep 2012 | hepatic encephalopathy | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 106 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lactulose | “A full-dose regimen of lactulose for oral solution, where all dosing is completed the evening prior to the colonoscopy procedure, will be studied and compared to a split-dose...” NCT01887470 ↗102“nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be...” NCT04013113 ↗ “Lactulose ± rifaximin as SoC treatment for overt HE should be administered per the clinical judgement of the investigator and usual institutional practice.” NCT04128462 ↗ “Standard Medical Therapy will include nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics as required” NCT03420144 ↗ “with all subjects receiving oral Lactulose 10 GM plus IV escalating 6β-Naltrexol 0.05 mg, 0.15 mg, 0.5 mg with a randomized placebo” NCT00829777 ↗ “An osmotic laxative medication (Lactulose) is thought to be a green light medication for a three-month period of program.” NCT06082622 ↗ “Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days” NCT01124318 ↗ “Nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics.” NCT03415698 ↗ “Drugs used for Cirrhosis management such as Diuretics, Hepatoprotective agents and Lactulose” NCT04243681 ↗ “The intervention group received lactulose and enemas to produce 1-2 defecations per day.” PMID 26373705 ↗ Sep 2015 “Lactulose (Duphalac (r)) is a disaccharide, semi-synthetic derivative of lactulose.” NCT06666556 ↗ |
| Known as | Duphalac | “In the LOS group, patients were instructed to drink 200ml lactulose (Duphalac, Olst, the Netherlands; 200ml/bottle) diluted with clear water into 1L 4-6h before colonoscopy at...” NCT05648318 ↗ |
| Known as | Duphalac (r) | “Lactulose (Duphalac (r)) is a disaccharide, semi-synthetic derivative of lactulose.” NCT06666556 ↗ |
| Known as | Duphlac, lactulose | “Duphlac, lactulose” NCT03100513 ↗ |
| Known as | Kristalose | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01256541 ↗ |
| Known as | LAC | “Lactulose (LAC) is widely used in treating constipation.” NCT05726344 ↗ |
| Known as | Lactofiltrum | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01089348 ↗ |
| Known as | Lactulose Oral Solution | “Oral administration of Lactulose Oral Solution (15 mL once daily) combined with routine postoperative care for 8 consecutive weeks.” NCT07648394 ↗ |
| Known as | Laevolac | “67% lactulose in the original preparation (Laevolac, Fresenius Kabi, Austria) was diluted by distilled water to 33.5% preparation in the pharmacy in strict sterile conditions...” NCT00616876 ↗ |
| Action | Inhibit | “inhibits ammoniagenic coliform bacteria” NCT02464124 ↗ |
| Modality | Other / unclassified | “The treatment of choice is non-absorbable disaccharides, such as lactulose and lactitol.” NCT01178372 ↗ |
| Route | Oral | “Lactulose Oral Solution was taken orally” NCT00508482 ↗ |