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 Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Purdue Pharma LP
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Overall complete spontaneous bowel movement (CSBM) responder rates
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
OXN
Oxycodone/Naloxone controlled-release tablets (OXN)
Intervention: Oxycodone/Naloxone controlled-release (Drug)
OXY
Oxycodone HCl controlled-release tablets (OXY)
Intervention: Oxycodone HCl controlled-release (Drug)
Placebo
Placebo tablets to match OXN or OXY
Intervention: Placebo (Drug)
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)