A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
Phase 3
Completed
- Conditions
- Low Back Pain
- Interventions
- Registration Number
- NCT01427283
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OXY Oxycodone HCl controlled-release Oxycodone HCl controlled-release tablets (OXY) OXN Oxycodone/Naloxone controlled-release Oxycodone/Naloxone controlled-release tablets (OXN) Placebo Placebo Placebo tablets to match OXN or OXY
- Primary Outcome Measures
Name Time Method Overall complete spontaneous bowel movement (CSBM) responder rates 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Investigational Site
🇺🇸Bothell, Washington, United States