Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Drug: Placebo
- Registration Number
- NCT00490919
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) 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 settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 539
- Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening,
- Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of <5 mg oxycodone (or equivalent) per day,
- Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy
- Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period,
- Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids,
- Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.
Other protocol-specific inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double-blind BTDS 10 or 20 Buprenorphine transdermal system Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear Double-blind Placebo TDS Placebo Placebo transdermal system to match BTDS patches, applied for 7 days
- Primary Outcome Measures
Name Time Method Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase. Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase. Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.
- Secondary Outcome Measures
Name Time Method The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase weeks 2-12 Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen.
The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase Weeks 4, 8, 12 of double-blind phase The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.
Trial Locations
- Locations (24)
Dolby Research, LLC
🇺🇸Baton Rouge, Louisiana, United States
Arizona Research Center Inc.
🇺🇸Phoenix, Arizona, United States
Pharmax Research Clinic
🇺🇸Miami, Florida, United States
Anderson Family Care, PA
🇺🇸Anderson, South Carolina, United States
Community Research
🇺🇸Cincinatti, Ohio, United States
Independent Neurodiagnostic Clinic
🇺🇸Atlanta, Georgia, United States
Lovelace Scientific Resources, Inc.
🇺🇸Beverly Hills, California, United States
University Clinical Research
🇺🇸Deland, Florida, United States
Advance Care Medical Group
🇺🇸City of Industry, California, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Radiant Research; Phoenix Southeast
🇺🇸Chandler, Arizona, United States
Century Clinical Research, Inc.
🇺🇸Holly Hill, Florida, United States
Rehabilitation Association of IN
🇺🇸Indianapolis, Indiana, United States
Clinical Research of West Flor
🇺🇸Tampa, Florida, United States
Druid Oaks Health Center
🇺🇸Decatur, Georgia, United States
Sports Med Consultants, PC
🇺🇸St. Louis, Missouri, United States
KRK Medical Research
🇺🇸Dallas, Texas, United States
Arthritis Associates of S. FL
🇺🇸Delray Beach, Florida, United States
Research Facility
🇺🇸Roanoke, Virginia, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
CTT Consultants, Inc.
🇺🇸Prairie Village, Kansas, United States
East Coast Clinical Research
🇺🇸Haverhill, Massachusetts, United States
Lovelace Scientific Resources
🇺🇸Albuquerque, New Mexico, United States
New England Center for Clinical Research
🇺🇸Cranston, Rhode Island, United States