Drugs / Hydrocodone
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Hydrocodone

Developed for
chronic pain syndrome · carpal tunnel syndrome · musculoskeletal system disorder · neuropathy, painful · tooth disorder · de Quervain disease · dementia · disease of bone structure
+5 more · ganglion or cyst of synovium/tendon/bursa · nephrolithiasis · osteoarthritis, knee · pregnancy disorder with abortive outcome · rotator cuff syndrome
Investigated by
Cephalon · Charleston Laboratories, Inc · Purdue Pharma LP · Sun Pharma Advanced Research Company Limited · Zogenix, Inc. · Abbott
+29 more · Loma Linda University · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Mallinckrodt · Teva Branded Pharmaceutical Products R&D, Inc. · VA Office of Research and Development · AbbVie · Canadian Institutes of Health Research (CIHR) · Carilion Clinic · Grünenthal GmbH · Horizon Health Network · Jefferson Medical College of Thomas Jefferson University · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Le Bonheur Children's Hospital · McGill University · Montefiore Medical Center · OrthoCarolina Research Institute, Inc. · PriCara, Unit of Ortho-McNeil, Inc. · Reckitt Benckiser Inc. · Rush University Medical Center · Sanford Health · Syneos Health · The Campbell Foundation · The University of Texas Health Science Center, Houston · Timothy L. Brown · Universidad Europea de Canarias · University of Illinois College of Medicine at Peoria · University of Michigan · University of Minnesota · University of Western Ontario, Canada

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) LORTAB 1982-07-09 fda.gov

Trials 40 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02540512 Jul → Sep 2017 musculoskeletal system disorder Loma Linda University Withdrawn No outcome recorded
Phase 115 trials
Phase 1 NCT03567941 Dec 2017 → Oct 2018 Sun Pharma Advanced Research Company Limited Completed No outcome recorded
Phase 1 NCT03137030 Sep 2017 → Jan 2018 substance-related disorder Grünenthal GmbH Withdrawn No outcome recorded
Phase 1 NCT02991261 Feb → Mar 2017 Sun Pharma Advanced Research Company Limited Completed No outcome recorded
Phase 1 NCT02618395 Dec 2015 → Jan 2016 Sun Pharma Advanced Research Company Limited Completed No outcome recorded
Phase 1 NCT02561741 Dec 2012 Mallinckrodt Completed No outcome recorded
Phase 1 NCT02243241 Nov 2012 → May 2013 Purdue Pharma LP Completed No outcome recorded
Phase 1 NCT01596673 Mar → May 2012 substance abuse Cephalon Completed No outcome recorded
Phase 1 NCT01319279 Apr → Aug 2011 Cephalon Completed No outcome recorded
Phase 1 NCT01319266 Mar → Oct 2011 impaired renal function disease Cephalon Completed No outcome recorded
Phase 1 NCT02244762 Feb → May 2011 impaired renal function disease Zogenix, Inc. Completed No outcome recorded
Phase 21 trial
Phase 2 NCT01364922 Jun → Oct 2011 chronic pain syndrome AbbVie Completed No outcome recorded
Phase 312 trials
Phase 3 NCT03586934 Jun 2018 → Jun 2019 substance-related disorder Rush University Medical Center Withdrawn No outcome recorded
Phase 3 NCT03404518 Feb → Oct 2018 Loma Linda University Completed No outcome recorded
Phase 3 NCT03657810 Aug 2017 → Apr 2018 Charleston Laboratories, Inc Completed No outcome recorded
Phase 3 NCT02487108 Aug 2015 → Mar 2016 Teva Branded Pharmaceutical Products R&D, Inc. Completed No outcome recorded
Phase 3 NCT02462850 Oct 2014 → Jan 2015 Charleston Laboratories, Inc Completed No outcome recorded
Phase 3 NCT01789970 Mar 2013 → Feb 2014 Teva Branded Pharmaceutical Products R&D, Inc. Completed No outcome recorded
Phase 3 NCT01780428 Jan → Oct 2013 Charleston Laboratories, Inc Completed No outcome recorded
Phase 3 NCT01402375 Jan 2012 → Nov 2014 Montefiore Medical Center Completed No outcome recorded
Phase 3 NCT01452529 Oct 2011 → Sep 2013 chronic pain syndrome Purdue Pharma LP Completed No outcome recorded
Phase 3 NCT01400139 Jul 2011 → Aug 2013 chronic pain syndrome Purdue Pharma LP Completed No outcome recorded
Phase 47 trials
Phase 4 NCT04905563 Jun 2021 → Jan 2024 Le Bonheur Children's Hospital Terminated No outcome recorded
Phase 4 NCT03375593 Aug 2019 → Oct 2021 London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Unknown No outcome recorded
Phase 4 NCT03372382 Dec 2017 → Apr 2018 substance-related disorder The University of Texas Health Science Center, Houston Completed 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 NCT03447353 Jun → Oct 2016 Timothy L. Brown Completed No outcome recorded
Phase 4 NCT01974609 Mar 2016 → Feb 2022 carpal tunnel syndrome Horizon Health Network Completed No outcome recorded
Phase 4 NCT00385684 Oct 2007 → Dec 2011 Alzheimer disease, vascular dementia VA Office of Research and Development Completed No outcome recorded
Phase not applicable4 trials
NCT06240390 May → Aug 2024 neuropathy, painful Universidad Europea de Canarias Withdrawn No outcome recorded
NCT04176783 Mar 2018 → Jul 2021 OrthoCarolina Research Institute, Inc. Completed No outcome recorded
NCT01982799 Feb 2014 → Sep 2015 tooth disorder University of Minnesota Withdrawn No outcome recorded
NCT00386243 Dec 2007 → May 2012 chronic pain syndrome VA Office of Research and Development Completed No outcome recorded
Also used as a comparator or background therapy in 70 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 04 trials
Phase 0 NCT03820193 Comparator Jan 2019 → Jun 2020 substance-related disorder Henry Ford Health System Completed No outcome recorded
Phase 0 NCT03579446 Background Nov 2018 → Jun 2023 hematopoietic and lymphoid cell neoplasm, metastatic malignant neoplasm M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 0 NCT06484439 Comparator Feb 2018 → Nov 2021 impacted teeth, multiple, neuropathy, painful United States Naval Medical Center, San Diego Completed No outcome recorded
Phase 0 NCT02373254 Comparator Jan → Oct 2015 University of California, Davis Completed No outcome recorded
Phase 16 trials
Phase 1 NCT03640247 Background Nov 2018 → Dec 2019 parathyroid gland disorder, thyroid gland disorder MetroHealth Medical Center Completed No outcome recorded
Phase 1 NCT03137017 Comparator Sep → Nov 2017 substance-related disorder Grünenthal GmbH Withdrawn No outcome recorded
Phase 1 NCT02033707 Background Apr 2014 → Feb 2019 Johns Hopkins University Completed No outcome recorded
Phase 1 NCT01668849 Comparator Aug 2012 → May 2022 chemotherapy-induced oral mucositis, head and neck cancer University of Louisville Completed No outcome recorded
Phase 1 NCT00802087 Comparator Nov → Dec 2008 Egalet Ltd Completed No outcome recorded
Phase 29 trials
Phase 2 NCT06780202 Background Jan 2025 → Jun 2027 expected Emory University Recruiting No outcome recorded
Phase 2 NCT06619847 Comparator Oct 2024 → May 2025 Vertex Pharmaceuticals Incorporated Completed No outcome recorded
Phase 2 NCT06232577 Background Mar 2024 → May 2027 expected M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT03584152 Comparator Aug 2019 → Nov 2024 neuropathy, painful Stanford University Completed No outcome recorded
Phase 2 NCT03879408 Comparator May → Nov 2019 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT04939987 Comparator Aug → Oct 2022 Wake Forest University Health Sciences Withdrawn No outcome recorded
Phase 2/3 NCT03825809 Comparator Jan 2019 → Jan 2020 overdue substance-related disorder Henry Ford Health System Recruiting No outcome recorded
Phase 2/3 NCT03818932 Comparator Jan 2019 → Jan 2020 Henry Ford Health System Completed No outcome recorded
Phase 37 trials
Phase 3 NCT07296770 Background Oct 2026 → Dec 2027 expected chronic pain syndrome University of California, San Francisco Not yet recruiting No outcome recorded
Phase 3 NCT04452344 Comparator Jan 2021 → Jul 2023 overdue substance-related disorder Rutgers, The State University of New Jersey Active not recruiting No outcome recorded
Phase 3 NCT05283499 Comparator Jul 2020 → Mar 2021 Rutgers, The State University of New Jersey Completed No outcome recorded
Phase 3 NCT03823534 Background Feb 2019 → Dec 2026 expected bone neoplasm, plasma cell myeloma, substance-related disorder St. Louis University Recruiting No outcome recorded
Phase 3 NCT04872322 Comparator Aug 2017 → Dec 2021 Rothman Institute Orthopaedics Unknown No outcome recorded
Phase 434 trials
Phase 4 NCT07575230 Comparator Nov 2025 → Dec 2027 expected skin neoplasm Baylor Research Institute Enrolling by invitation No outcome recorded
Phase 4 NCT07158476 Comparator Oct 2025 → Sep 2030 expected St. Louis University Recruiting No outcome recorded
Phase 4 NCT06935331 Comparator Oct 2025 → Dec 2026 expected adolescent idiopathic scoliosis OrthoCarolina Research Institute, Inc. Enrolling by invitation No outcome recorded
Phase 4 NCT07195669 Comparator Oct → Dec 2025 overdue Jacob Lensing Not yet recruiting No outcome recorded
Phase 4 NCT06113211 Comparator Oct 2024 → Sep 2026 expected disease of bone structure, substance-related disorder Henry Ford Health System Recruiting No outcome recorded
Phase not applicable7 trials
NCT02625181 Background Jul 2016 → Nov 2017 Vanderbilt University Completed No outcome recorded
NCT03996564 Comparator Feb → Dec 2016 San Antonio Military Medical Center Completed No outcome recorded
NCT02236130 Background Jun 2014 → Jun 2015 University of Mississippi Medical Center Terminated No outcome recorded
NCT02136784 Comparator Apr → Dec 2014 University of California, Los Angeles Unknown No outcome recorded
NCT02312739 Comparator Feb 2014 → Mar 2015 University of New Mexico Completed No outcome recorded

Press releases naming this drug 7 releases

DateIssuerRelease
2017-01-18 Teva Branded Pharmaceutical Products R&D, Inc. Teva Receives FDA Approval for VANTRELATM ER (Hydrocodone Bitartrate) Extended-Release Tablets [CII] Formulated with Proprietary Abuse Deterrence Technology tevapharm.com
2016-06-07 Teva Branded Pharmaceutical Products R&D, Inc. Teva Gains Recommendation for Approval from FDA Advisory Committees for VANTRELA™ ER (hydrocodone bitartrate) Extended-Release Tablets CII Formulated with Proprietary Abuse Deterrence Technology tevapharm.com
2015-02-25 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces FDA Acceptance for Review of NDA for its Investigational Twice-Daily Hydrocodone Bitartrate Extended-Release Tablets with Proprietary Abuse Deterrence Technology tevapharm.com
2014-10-08 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Initiation of New Drug Application and Positive Results from Second Human Abuse Liability Study for CEP-33237 (Hydrocodone Bitartrate) Extended-Release Tablets tevapharm.com
2014-04-30 Teva Branded Pharmaceutical Products R&D, Inc. Teva Reports Positive Results from Pivotal Phase III Study to Evaluate Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Moderate to Severe Chronic Low Back Pain tevapharm.com
2003-04-14 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Approval of Hydrocodone Bitartrate and Ibuprofen Tablets tevapharm.com
2002-09-12 Teva Branded Pharmaceutical Products R&D, Inc. Judge Grants Teva Summary Judgment of Invalidity for Patent Related to Hydrocodone Bitartrate and Ibuprofen Tablets tevapharm.com

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 110 sources stand behind the page.

FieldValueCited text
Known as Hydrocodone “A Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 4-Way Crossover Study to Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and...” NCT03567941
86

“The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone bitartrate/acetaminophen immediate-release tablets at doses of 5.0 milligrams (mg)/325...” NCT02487108

“Biphasic immediate-release (IR)/extended-release (ER) hydrocodone bitartrate (HB)/acetaminophen (APAP) 7.5/325-mg tablets are formulated with gastroretentive ER drug delivery...” PMID 26614499 Nov 2015

“This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with...” NCT01780428

“This clinical trial is being conducted to compare concentrations of hydrocodone and acetaminophen in the blood after administration of different amounts of tablets of a new and...” NCT03137030

“Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate...” NCT02242734

“Evaluation of the Effect of Renal Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate...” NCT02244762

“A Pilot Study in Healthy Volunteers to Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release (HC-ER) Capsules, in Both Fed...” NCT02117141

Hydrocodone bitartrate 80 mg (day 9), 120 mg (day 12), 160 mg \[(1) 40 mg tablet + (1) 120 mg tablet\] (day 15) extended-release tablets administered orally every 24 hours.” NCT02243241

“Participants were randomized to receive 5 mg of hydrocodone with 300 mg of acetaminophen (opioid) or 400 mg of ibuprofen and 500 mg of acetaminophen (nonopioid).” PMID 39755971 Jan 2025

“Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).” NCT03605914

“women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco)” NCT03372382

“Participants will receive the standard of care drug Norco (a medicine that combines hydrocodone and acetaminophen).” NCT07575230

“oral analgesia/anxiolysis (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg)” NCT01011634

“Acetaminophen (325mg) + Hydrocodone (5mg) compared to Acetaminophen(325mg) + Ibuprofen (200mg)” NCT03584152

“medications in the opioid family such as Hydromorphone, Hydrocodone, Tramadol, or Oxycodone.” NCT04176783

“Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone)” NCT03472469

Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control” NCT03404518

Hydrocodone bitartrate 5 mg/acetaminophen 325 mg tablet (Norco 5Mg-325Mg Tablet)” NCT03137017

“If intolerant to Oxycodone: second agent line is Hydrocodone or Oral Dilaudid” NCT02219581

“Opioids: heroin, morphine, oxycodone, hydrocodone, methadone, codeine” NCT02033707

“CL-108 Hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg” NCT02462850

“Norco (acetaminophen/hydrocodone) 10/325 mg po q 6 hours PRN pain.” NCT02373254

“Combination analgesic of hydrocodone 5mg/acetaminophen350 mg” NCT05283499

Hydrocodone 5 mg/Acetaminophen 325 mg/Promethazine 12.5 mg” NCT03657810

“20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)” NCT03457116

“one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet” NCT02312739

Hydrocodone Bitartrate Extended Release (HC-ER)” NCT02197156

Hydrocodone bitartrate/acetaminophen (HB/APAP)” NCT06619847

Hydrocodone 5 mg every 6 hours prn for pain” NCT03640247

“Oral narcotic (hydrocodone/acetaminophen)” NCT06935331

Hydrocodone Bitartrate and Acetaminophen” NCT07296770

“Vicodin (acetaminophen and hydrocodone)” NCT04008043

Hydrocodone 5mg + acetaminophen 325 mg” NCT01974609

“Acetaminophen/hydrocodone (500mg/5mg).” NCT00386243

Hydrocodone Oxymorphone (Opana®)” NCT06240390

NCT00853190

NCT02136784

NCT03206723

NCT02029235

NCT02358850

NCT02625181

NCT04149964

NCT03642873

NCT03375593

NCT03173456

NCT00314340

NCT01789970

NCT00802087

NCT02462811

NCT01452529

NCT02540512

NCT00574015

NCT07158476

NCT00429468

NCT01859715

NCT03579446

NCT01402375

NCT05640674

NCT04307940

NCT03879408

NCT00236535

NCT03996564

NCT00853294

NCT03823534

NCT01596673

NCT01330459

NCT00325949

NCT01400139

NCT01319279

NCT02296840

NCT01319266

NCT06780202

NCT06484439

NCT06187584

NCT00385684

NCT02455518

NCT05024825

NCT03619785

NCT01517295

NCT02618395

NCT04905563

NCT05544734

NCT06232577

NCT03586934

NCT01982799

NCT02236130

Known as HC-ER “Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate...” NCT02242734
1

“Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg Capsules” NCT02244762

Known as Hycet ClinicalTrials.gov intervention name — accepted as the source's own label NCT04240626
Known as HYD “The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects” NCT02243241
Known as Hydrocodon ClinicalTrials.gov intervention name — accepted as the source's own label NCT03820193
Known as Hydrocodone Bitartrate “An Open-Label, Single-Dose Study to Assess the Pharmacokinetics of the Hydrocodone Bitartrate Extended-Release Tablet (45 mg) in Subjects With Normal Renal Function and...” NCT01319266
3

“Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate...” NCT02242734

“The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects” NCT02243241

Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg Capsules” NCT02244762

Known as Hydrocodone ER Hydrocodone ER was taken by participants randomized to the hydrocodone ER treatment arm during the double-blind treatment period at the dose level identified during the...” NCT01789970
Known as Hydrocodone-Acetaminophen hydrocodone-acetaminophen 5mg/325mg 1 tablet q6hrs PRN to start on POD0 30 tablets” NCT07037888
7

Hydrocodone-acetaminophenNCT02991261

NCT03818919

NCT03818932

NCT03121963

NCT03825809

NCT02958566

NCT04939987

Known as hydrocodone/acetaminophen extended release ClinicalTrials.gov intervention name — accepted as the source's own label NCT01364922
Known as Lortab ClinicalTrials.gov intervention name — accepted as the source's own label NCT01668849
1

NCT01708473

Known as Norco “The traditional narcotic intervention is: 60 pills of Norco 5-325 q4 hours PRN.” NCT06113211
6

NCT03872843

NCT03447353

NCT07195669

NCT04872322

NCT03858231

NCT02381132

Known as Vicodin “Patients will also receive a prescription for Vicodin as needed for pain, every 4 to 6 hours” NCT01628367
2

NCT01588158

NCT02110719

Route Oral oral hydrocodone 10 mg/acetaminophen 650 mg” NCT00574015