Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
Recruiting in Palo Alto (17 mi)
+84 other locations
Overseen byMartin Hale, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Purdue Pharma LP
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
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.
Treatment Details
Interventions
- Buprenorphine Transdermal System (Opioid Analgesic)
- Oxycodone Immediate-Release (Opioid Analgesic)
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Oxycodone Immediate-ReleaseExperimental Treatment1 Intervention
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Group II: BTDS 20Experimental Treatment1 Intervention
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Group III: BTDS 5Active Control1 Intervention
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Shreenath Clinical ServiceFountain Valley, CA
Lovelace Scientific ResourcesHenderson, NV
PharmquestGreensboro, NC
BioMedical Research AssociatesShippensburg, PA
More Trial Locations
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Who Is Running the Clinical Trial?
Purdue Pharma LPLead Sponsor