CLINICAL TRIALS PROFILE FOR NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
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All Clinical Trials for naltrexone hydrochloride; oxycodone hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | 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 | 2007-08-01 | 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 | 2010-12-01 | 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 | 2011-10-01 | 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 | 2012-02-01 | 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 | 2012-06-01 | 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 | 2012-09-01 | 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 | 2012-09-01 | 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 | >Start Date | >Summary |
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