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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

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Clinical Trials for Naltrexone Hydrochloride; Oxycodone Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00734461 Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse Completed Pain Therapeutics Phase 2 This is a single-center, randomized, 7-way crossover, double-blind, active and placebo-controlled study to evaluate the subjective effects of oxycodone combined with ultra-low dose naltrexone in comparison to oxycodone alone in non-physically dependent subjects with a history of opioid abuse. Approximately 14 subjects will be randomized to one of fourteen sequences selected from a balanced 7x7 Latin square design and its mirror image.
NCT01428583 Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain Completed Pfizer Phase 3 The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.
NCT01456507 Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone Completed Pfizer Phase 1 The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.
NCT01559454 Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients Completed State University of New York at Buffalo Phase 4 Chronic pain patients are treated with prescription opioids and many exhibit opioid addiction. Currently, there are no evidence-based guidelines to better manage patients with chronic pain and coexistent opioid addiction. This study compares 6-months buprenorphine and methadone treatment in these patients. The investigators hypothesize that both buprenorphine and methadone treatment will reduce pain and addiction behaviors and increase functioning in these patients.
NCT01571362 A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain Completed Pfizer Phase 3 The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.
NCT01677039 Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation Completed Pfizer Phase 1 The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary pharmacokinetic parameters are the peak concentration of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area under the plasma concentration-time curve (AUC).
NCT01677065 A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers Completed Pfizer Phase 1 To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Naltrexone Hydrochloride; Oxycodone Hydrochloride

Condition Name

Condition Name for Naltrexone Hydrochloride; Oxycodone Hydrochloride
Intervention Trials
Healthy 9
Low Back Pain 2
Chronic Pain 1
Withdrawal Symptoms 1
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Condition MeSH

Condition MeSH for Naltrexone Hydrochloride; Oxycodone Hydrochloride
Intervention Trials
Low Back Pain 2
Back Pain 2
Substance-Related Disorders 1
Opioid-Related Disorders 1
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Clinical Trial Locations for Naltrexone Hydrochloride; Oxycodone Hydrochloride

Trials by Country

Trials by Country for Naltrexone Hydrochloride; Oxycodone Hydrochloride
Location Trials
United States 59
Canada 2
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Trials by US State

Trials by US State for Naltrexone Hydrochloride; Oxycodone Hydrochloride
Location Trials
Maryland 5
Texas 4
New York 4
Connecticut 4
Georgia 3
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Clinical Trial Progress for Naltrexone Hydrochloride; Oxycodone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Naltrexone Hydrochloride; Oxycodone Hydrochloride
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Naltrexone Hydrochloride; Oxycodone Hydrochloride
Clinical Trial Phase Trials
Completed 14
Recruiting 2
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Clinical Trial Sponsors for Naltrexone Hydrochloride; Oxycodone Hydrochloride

Sponsor Name

Sponsor Name for Naltrexone Hydrochloride; Oxycodone Hydrochloride
Sponsor Trials
Pfizer 9
Pain Therapeutics 3
Elite Laboratories, Inc 2
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Sponsor Type

Sponsor Type for Naltrexone Hydrochloride; Oxycodone Hydrochloride
Sponsor Trials
Industry 16
Other 4
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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Deloitte
Citi
Merck
Baxter
McKesson
Covington
Federal Trade Commission
McKinsey

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