NCT01358526

Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,095 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Oxycodone/Naloxone Controlled-release	Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
DRUG	Placebo	Placebo tablets to match OXN taken orally every 12 hours

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2011-05-23
• Last updated: 2015-11-11
• Results posted: 2014-09-03

Locations

151 sites across 1 country: United States