CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 395 enrolled
Drug / intervention
oxycodone HCl and naltrexone HCl extended-release capsulesdrug
Likely dose
oxycodone HCl and naltrexone HCl extended-release capsules 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01428583
NCT01428583Phase 3Completed
CompareCT.gov

A Multicenter, 12-month, Open-label, Single-arm, Safety Study Of Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended-release Capsules In Subjects With Moderate To Severe Chronic Noncancer Pain

Pfizer·interventional·Posted Sep 5, 2011·Updated Nov 21, 2016

In Brief

A Phase 3 clinical trial evaluating oxycodone HCl and naltrexone HCl extended-release capsules for Chronic Noncancer Pain. Completed, enrolled 395 participants across 32 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Noncancer Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 5, 2011
Enrollment StartDec 1, 2010
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.8 years ago

Interventions

oxycodone HCl and naltrexone HCl extended-release capsulesdrug

Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.)