CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 23 enrolled
Drug / intervention
Oxycodone hydrochloride controlled-release tabletsdrug
Likely dose
Oxycodone hydrochloride controlled-release tablets 40 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/NCT01369615
NCT01369615Phase 3Completed
CompareCT.gov

An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study

Purdue Pharma LP·interventional·Posted Jun 9, 2011·Updated Sep 9, 2015

In Brief

A Phase 3 clinical trial evaluating Oxycodone hydrochloride controlled-release tablets for Pain. Completed, enrolled 23 participants across 14 sites in 2 countries.

Detailed Summary

The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in OTR3001.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesIsrael, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 9, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.1 years ago

Interventions

Oxycodone hydrochloride controlled-release tabletsdrug

Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.