A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-release Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Purdue Pharma LP
- Enrollment
- 660
- Locations
- 82
- Primary Endpoint
- Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.
Study Overview
Brief Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.
Detailed Description
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •low back pain for 3 months or longer, confirmed by radiographic evidence.
- •receiving a stable dose of an opioid analgesic for low back pain.
Exclusion Criteria
- •taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
- •requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.
- •Other protocol-specific exclusion/inclusion criteria may apply.
Arms & Interventions
BTDS 5
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Intervention: Buprenorphine (Drug)
BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Intervention: Buprenorphine (Drug)
Oxycodone Immediate-Release
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Intervention: Oxycodone Immediate-Release (Drug)
Outcomes
Primary Outcomes
Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.
Time Frame: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase
Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)
Secondary Outcomes
- Mean Daily Number of Supplemental Analgesic Tablets(Double-blind phase (84 days))
- Oswestry Disability Index (ODI) Score (V 2.0)(Weeks 4, 8, 12)
- The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.(Weeks 4, 8, 12 of the double-blind phase)