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
Overview
- Phase
- Phase 3
- Intervention
- Oxycodone/Naloxone controlled-release
- Conditions
- Low Back Pain
- Sponsor
- Purdue Pharma LP
- Enrollment
- 455
- Locations
- 1
- Primary Endpoint
- Overall complete spontaneous bowel movement (CSBM) responder rates
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
OXN
Oxycodone/Naloxone controlled-release tablets (OXN)
Intervention: Oxycodone/Naloxone controlled-release
OXY
Oxycodone HCl controlled-release tablets (OXY)
Intervention: Oxycodone HCl controlled-release
Placebo
Placebo tablets to match OXN or OXY
Intervention: Placebo
Outcomes
Primary Outcomes
Overall complete spontaneous bowel movement (CSBM) responder rates
Time Frame: Weeks 1 through 12
The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY
Secondary Outcomes
- CSBM Responder at least 50% of the weeks in the double-blind period(Weeks 1 through 12)
- Laxative-free Responder at least 50% of the weeks in the double-blind period(Weeks 1 through 12)