17 completed, 1 not yet recruiting, 1 withdrawn. 19 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 19 | Completed 17, Not yet recruiting 1, Withdrawn 1 |
Follow Hydrocodone: new trials by email Literature Review of Hydrocodone trials Research Report on Hydrocodone
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service TPS-Select, Pharmacologic Pain Management, Interventional Pain Procedures - Postsurgical Pain Management, Postsurgical Pain, Chronic | Phase 3 | Not yet recruiting | University of California, San Francisco | 474 | 2026-10-01 | 2026-10-09 |
| Multimodal Analgesia in Shoulder Arthroplasty Acetaminophen, Celecoxib 200mg, Celecoxib 400 mg - Shoulder Pain, Opioid Use | Phase 3 | Withdrawn | Rush University Medical Center | 2018-06-01 | 2021-09-28 | |
| A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV CL-108 5 mg, Norco, Placebo - Pain, Nausea | Phase 3 | Completed | Charleston Laboratories, Inc | 349 | 2017-08-02 | 2023-03-22 |
| Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Participants With Moderate to Severe Pain Following Bunionectomy TV-46763, Placebo - Pain | Phase 3 | Completed | Teva Branded Pharmaceutical Products R&D, Inc. | 569 | 2015-08-11 | 2022-03-31 |
| A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV) CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg), Placebo, Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg) - Pain, Nausea | Phase 3 | Completed | Joseph Hazelton | 552 | 2014-09-01 | 2016-11-03 |
| Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg), Placebo - Pain, Nausea | Phase 3 | Completed | Charleston Laboratories, Inc | 460 | 2013-01-01 | 2016-11-03 |
| Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge Hydrocodone (first trial), Codeine (first trial), Oxycodone (for second trial) - Analgesia After ED Discharge for Extremity Injuries | Phase 3 | Completed | Montefiore Medical Center | 720 | 2012-01-01 | 2018-05-01 |
| Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain Hydrocodone bitartrate q24h film-coated tablets, Placebo to match hydrocodone bitartrate q24h tablets - Chronic Low Back Pain | Phase 3 | Completed | Purdue Pharma LP | 905 | 2011-10-01 | 2020-03-10 |
| Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period. Hydrocodone bitartrate q24h film-coated tablets - Chronic Nonmalignant and Nonneuropathic Pain | Phase 3 | Completed | Purdue Pharma LP | 922 | 2011-07-01 | 2020-03-10 |
| Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain Hydrocodone Bitartrate - Chronic Pain | Phase 3 | Completed | Zogenix, Inc. | 424 | 2010-05-01 | 2022-11-09 |
| Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain Placebo, Hydrocodone bitartrate - Back Pain Lower Back Chronic | Phase 3 | Completed | Zogenix, Inc. | 510 | 2010-03-01 | 2022-12-08 |
| Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) ABT-712, Placebo - Chronic Low Back Pain | Phase 3 | Completed | AbbVie (prior sponsor, Abbott) | 287 | 2008-09-01 | 2014-02-06 |
| Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) ABT-712, Placebo - Chronic Low Back Pain | Phase 3 | Completed | AbbVie (prior sponsor, Abbott) | 308 | 2008-09-01 | 2014-02-07 |
| A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy Hydrocodone/Acetaminophen Extended-Release, Hydrocodone/Acetaminophen Extended Release, Placebo - Pain | Phase 3 | Completed | Abbott | 150 | 2006-12-01 | 2011-01-25 |
| A Study of Pain Relief in Low Back Pain Extended release hydrocodone and acetaminophen (Vicodin CR), hydrocodone/acetaminophen extended release (Vicodin CR), placebo - Chronic Low Back Pain | Phase 3 | Completed | Abbott | 770 | 2006-05-01 | 2011-07-25 |
| A Study of Pain Relief in Osteoarthritis hydrocodone / acetaminophen extended release, Placebo - Osteoarthritis | Phase 3 | Completed | Abbott | 873 | 2006-02-01 | 2011-01-25 |
| Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain Hydrocodone/Acetaminophen on Extended Release - Moderate to Severe Chronic, Non-malignant Pain | Phase 3 | Completed | Abbott | 431 | 2005-06-01 | 2011-01-19 |
| A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament tramadol HCl + acetaminophen; hydrocodone bitartrate + acetaminophen; placebo - Sprains and Strains, Pain | Phase 3 | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 603 | 2003-12-01 | 2011-06-10 |
| Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED) MK0966 / Duration of Treatment: 1 Days, Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days, Comparator: placebo (unspecified) / Duration of Treatment: 1 Days - Pain, Postoperative Arthroscopy | Phase 3 | Completed | Merck Sharp & Dohme LLC | 420 | 2002-02-01 | 2017-02-02 |
Pain (10) · Nausea (3) · Vomiting (3) · Chronic Pain (2) · Agnosia (1) · Ankle Injuries (1) · Back Pain (1) · Osteoarthritis (1) · Osteoarthritis, Hip (1) · Pain, Postoperative (1) · Shoulder Pain (1) · Sprains and Strains (1)
Abbott (4) · AbbVie (prior sponsor, Abbott) (2) · Charleston Laboratories, Inc (2) · Purdue Pharma LP (2) · Zogenix, Inc. (2) · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (1) · Joseph Hazelton (1) · Merck Sharp & Dohme LLC (1) · Montefiore Medical Center (1) · Rush University Medical Center (1) · Teva Branded Pharmaceutical Products R&D, Inc. (1) · University of California, San Francisco (1)
United States (17)
Pedro Quintana Diez, MD (2) · Rita Jain, M.D. (2) · Rita Jain, MD (2) · Andrew Bishara, MD (1) · Andrew Chang, MD (1) · Bernard Schachtel, MD (1) · Gregory P Nicholson, MD (1) · Kevin Romanko, DPM (1) · Vickie Gorgone (1)
PMID 28072811, PMID 17113683, PMID 26111544, PMID 26312961, PMID 26681111, PMID 26749219