NCT01427270

Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC 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 - 40/20 mg) taken orally every 12 hours
DRUG	Oxycodone HCl controlled-release	Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
DRUG	Placebo	Placebo tablets to match OXN or OXY taken orally every 12 hours

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-09-01
• Last updated: 2014-11-07

Locations

194 sites across 4 countries: United States, Czechia, Italy, Poland