At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 740 enrolled
Drug / intervention
Oxycodone DETERx +1 moredrug
Likely dose
Oxycodone DETERx 160 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.
A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-Controlled, Safety, Tolerability, and Efficacy Study of Oxycodone DETERx™ Versus Placebo in Opioid-Experienced and Opioid-Naive Subjects With Moderate-to-Severe Chronic Low Back Pain
In Brief
A Phase 3 clinical trial evaluating Oxycodone DETERx and Placebo for Chronic Low Back Pain. Completed, enrolled 740 participants across 45 sites.
Detailed Summary
The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic low back pain requiring around-the-clock opioid analgesia for an extended period of time.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low Back Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2012
First PostedSep 2012
Primary CompletionJun 2014
Study CompletionJul 2014
TodayJul 2026
First PostedSep 14, 2012
Enrollment StartAug 1, 2012
Primary CompletionJun 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.8 years ago
Interventions
Oxycodone DETERxdrug
40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
Placebodrug
Placebo, divided into 2 doses, q12h