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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR ACETAMINOPHEN AND HYDROCODONE BITARTRATE


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All Clinical Trials for Acetaminophen And Hydrocodone Bitartrate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00236535 ↗ 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 Completed PriCara, Unit of Ortho-McNeil, Inc. Phase 3 2003-12-01 The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing acute musculoskeletal pain. Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription pain relief medication will be randomized to receive either tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or placebo.
NCT00236535 ↗ 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 Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 3 2003-12-01 The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing acute musculoskeletal pain. Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription pain relief medication will be randomized to receive either tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or placebo.
NCT01456520 ↗ Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco Completed Pfizer Phase 1 2011-10-01 This study aims to determine whether the hydrocodone and acetaminophen exposures following oral dosing of Vycavert are comparable to those following oral dosing of Norco.
NCT01596673 ↗ A Study to Assess the Abuse Potential of Hydrocodone Extended-Release Tablet in Recreational Opioid Users Completed Cephalon Phase 1 2012-03-01 The purpose of this study is to assess the relative abuse potential of the hydrocodone bitartrate extended-release tablet compared to immediate-release hydrocodone bitartrate.
NCT01759446 ↗ Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users Completed Acura Pharmaceuticals Inc. Phase 2 2013-02-01 To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when crushed and administered intranasally to non dependent, recreational opioid users.
NCT02487108 ↗ Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Patients With Moderate to Severe Pain Following Bunionectomy Completed INC Research Phase 3 2015-08-11 The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone bitartrate/acetaminophen immediate-release tablets at doses of 5.0 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating patients with moderate to severe pain following bunionectomy
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Acetaminophen And Hydrocodone Bitartrate

Condition Name

Condition Name for Acetaminophen And Hydrocodone Bitartrate
Intervention Trials
Opioid-Related Disorders 3
Healthy 2
Pain 2
Pain, Acute 2
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Condition MeSH

Condition MeSH for Acetaminophen And Hydrocodone Bitartrate
Intervention Trials
Opioid-Related Disorders 3
Acute Pain 2
Pain, Postoperative 2
Substance-Related Disorders 1
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Clinical Trial Locations for Acetaminophen And Hydrocodone Bitartrate

Trials by Country

Trials by Country for Acetaminophen And Hydrocodone Bitartrate
Location Trials
United States 10
Canada 2
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Trials by US State

Trials by US State for Acetaminophen And Hydrocodone Bitartrate
Location Trials
Utah 3
Kansas 2
Texas 1
Maryland 1
California 1
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Clinical Trial Progress for Acetaminophen And Hydrocodone Bitartrate

Clinical Trial Phase

Clinical Trial Phase for Acetaminophen And Hydrocodone Bitartrate
Clinical Trial Phase Trials
Phase 3 2
Phase 2 1
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for Acetaminophen And Hydrocodone Bitartrate
Clinical Trial Phase Trials
Completed 6
Withdrawn 2
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Clinical Trial Sponsors for Acetaminophen And Hydrocodone Bitartrate

Sponsor Name

Sponsor Name for Acetaminophen And Hydrocodone Bitartrate
Sponsor Trials
Grünenthal GmbH 2
Syneos Health 1
Teva Branded Pharmaceutical Products R&D, Inc. 1
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Sponsor Type

Sponsor Type for Acetaminophen And Hydrocodone Bitartrate
Sponsor Trials
Industry 10
Other 2
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