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Generated: March 24, 2019

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CLINICAL TRIALS PROFILE FOR HYDROCODONE BITARTRATE

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Clinical Trials for Hydrocodone Bitartrate

Trial ID Title Status Sponsor Phase 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 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 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.
NCT01081912 Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain Completed Zogenix, Inc. Phase 3 The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.
NCT01115569 Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain Completed Zogenix, Inc. Phase 3 This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.
NCT01223365 Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time Completed Cephalon Phase 3 The primary objective of this study is to evaluate the safety of hydrocodone extended-release tablets when used over a 12-month period in patients with chronic pain, as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Hydrocodone Bitartrate

Condition Name

Condition Name for Hydrocodone Bitartrate
Intervention Trials
Pain 6
Healthy 5
Opioid-Related Disorders 3
Hepatic Impairment 2
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Condition MeSH

Condition MeSH for Hydrocodone Bitartrate
Intervention Trials
Low Back Pain 5
Back Pain 5
Pain, Postoperative 3
Opioid-Related Disorders 3
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Clinical Trial Locations for Hydrocodone Bitartrate

Trials by Country

Trials by Country for Hydrocodone Bitartrate
Location Trials
United States 237
Canada 2
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Trials by US State

Trials by US State for Hydrocodone Bitartrate
Location Trials
Texas 12
Utah 11
Florida 10
Kansas 9
California 9
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Clinical Trial Progress for Hydrocodone Bitartrate

Clinical Trial Phase

Clinical Trial Phase for Hydrocodone Bitartrate
Clinical Trial Phase Trials
Phase 3 10
Phase 2 4
Phase 1 14
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Clinical Trial Status

Clinical Trial Status for Hydrocodone Bitartrate
Clinical Trial Phase Trials
Completed 24
Withdrawn 2
Recruiting 1
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Clinical Trial Sponsors for Hydrocodone Bitartrate

Sponsor Name

Sponsor Name for Hydrocodone Bitartrate
Sponsor Trials
Zogenix, Inc. 8
Cephalon 5
Purdue Pharma LP 4
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Sponsor Type

Sponsor Type for Hydrocodone Bitartrate
Sponsor Trials
Industry 29
Other 1
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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Colorcon
UBS
Argus Health
Daiichi Sankyo
Teva

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