Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
- Conditions
- Back Pain Lower Back Chronic
- Interventions
- Registration Number
- NCT00313014
- Lead Sponsor
- Purdue Pharma LP
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 660
- low back pain for 3 months or longer, confirmed by radiographic evidence.
- receiving a stable dose of an opioid analgesic for low back pain.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BTDS 5 Buprenorphine Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear. BTDS 20 Buprenorphine Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear. Oxycodone Immediate-Release Oxycodone Immediate-Release Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
- Primary Outcome Measures
Name Time Method Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. 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 Outcome Measures
Name Time Method Mean Daily Number of Supplemental Analgesic Tablets Double-blind phase (84 days) The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase
Oswestry Disability Index (ODI) Score (V 2.0) Weeks 4, 8, 12 The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes.
The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12. Weeks 4, 8, 12 of the double-blind phase The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath).
Question 1 is scored on a scale of 1 to 5 and Questions 3 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 (82)
Birmingham Pain Center
🇺🇸Birmingham, Alabama, United States
Arthritis Clinical Intervention Program
🇺🇸Birmingham, Alabama, United States
Winston Physician Services, LLC
🇺🇸Haleyville, Alabama, United States
Arizona Research Center, Inc.
🇺🇸Phoenix, Arizona, United States
Radiant Research
🇺🇸Phoenix, Arizona, United States
Advanced Clinical Therapeutics
🇺🇸Tuscon, Arizona, United States
Hot Springs Pain Clinic
🇺🇸Hot Springs, Arkansas, United States
NuLife Clinical Research, Inc.
🇺🇸Anaheim, California, United States
Lovelace Scientific Resources, Inc.
🇺🇸Beverly Hills, California, United States
Northern California Research Corp
🇺🇸Carmichael, California, United States
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