At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,095 enrolled
Drug / intervention
Oxycodone/Naloxone Controlled-release +1 moredrug
Likely dose
Oxycodone/Naloxone Controlled-release 5 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 Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Enriched Study Design to Assess the Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Pain Due to Chronic Low Back Pain Who Require Around-the-clock Opioid Therapy
In Brief
A Phase 3 clinical trial evaluating Oxycodone/Naloxone Controlled-release and Placebo for Low Back Pain. Completed, enrolled 1,095 participants across 151 sites.
Detailed Summary
The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedMay 2011
Primary CompletionOct 2012
Study CompletionNov 2012
TodayJul 2026
First PostedMay 23, 2011
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.1 years ago
Interventions
Oxycodone/Naloxone Controlled-releasedrug
Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
Placebodrug
Placebo tablets to match OXN taken orally every 12 hours