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)
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Vince and Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
Rheumatology PC
🇺🇸Kalamazoo, Michigan, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Renstar Medical
🇺🇸Ocala, Florida, United States
Medical Associates Clinics
🇺🇸Dubuque, Iowa, United States
Lovelace Scientific Resources, Inc.
🇺🇸Beverly Hills, California, United States
NuLife Clinical Research, Inc.
🇺🇸Anaheim, California, United States
University Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Winston Physician Services, LLC
🇺🇸Haleyville, Alabama, United States
Shreenath Clinical Service
🇺🇸Fountain Valley, California, United States
Peninsula Research Inc.
🇺🇸Ormond Beach, Florida, United States
Valley Pain Specialists
🇺🇸Bethlehem, Pennsylvania, United States
New England Center Clinical Research
🇺🇸Cranston, Rhode Island, United States
Gold Coast Research, LLC
🇺🇸Plantation, Florida, United States
Chiefland Medical Center
🇺🇸Chiefland, Florida, United States
Northern California Research Corp
🇺🇸Carmichael, California, United States
University Orthopedics Center
🇺🇸State College, Pennsylvania, United States
KRK Medical Research
🇺🇸Richardson, Texas, United States
Team Research of Central Texas
🇺🇸Harker Heights, Texas, United States
Galenos Research
🇺🇸Dallas, Texas, United States
Central Pennsylvania Clinical Research
🇺🇸Mechanicsburg, Pennsylvania, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Benchmark Research
🇺🇸San Angelo, Texas, United States
Clinical Trial Network Oaks Medical Center
🇺🇸Spring, Texas, United States
Accelovance
🇺🇸San Diego, California, United States
Hot Springs Pain Clinic
🇺🇸Hot Springs, Arkansas, United States
Pain Care Boise
🇺🇸Boise, Idaho, United States
Southern Colorado Clinic
🇺🇸Pueblo, Colorado, United States
CTT, Inc.
🇺🇸Prairie Village, Kansas, United States
Odyssey Research
🇺🇸Bismark, North Dakota, United States
Tri Cities Medical Research
🇺🇸Bristol, Tennessee, United States
Birmingham Pain Center
🇺🇸Birmingham, Alabama, United States
Arthritis Clinical Intervention Program
🇺🇸Birmingham, Alabama, United States
Arizona Research Center, Inc.
🇺🇸Phoenix, Arizona, United States
Pivotal Research Centers
🇺🇸North Las Vegas, Nevada, United States
Triangle Orthopaedic Associates
🇺🇸Durham, North Carolina, United States
COR Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Associated Medical Services
🇺🇸Oklahoma City, Oklahoma, United States
Unlimited Research
🇺🇸San Antonio, Texas, United States
Texas Medical Research Associates
🇺🇸San Antonio, Texas, United States
U of Calif at Davis, Med Ctr, Pain Management Center
🇺🇸Sacramento, California, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Georgia Medical Research Institute
🇺🇸Marietta, Georgia, United States
Drug Study Institute
🇺🇸Jupiter, Florida, United States
Atlanta Knee & Shoulder Clinic
🇺🇸Stockbridge, Georgia, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
N. Texas Neuro Research
🇺🇸Wichita Falls, Texas, United States
BioMedical Research Associates
🇺🇸Shippensburg, Pennsylvania, United States
GFI Research Center
🇺🇸Evansville, Indiana, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
The Arthritis Center
🇺🇸Palm Harbor, Florida, United States
International Clinical Research Network
🇺🇸Chula Vista, California, United States
Innovative Research of West Florida, Inc.
🇺🇸Largo, Florida, United States
Idaho Arthritis and Osteoporosis Center
🇺🇸Meridian, Idaho, United States
Coastal Medical Research
🇺🇸Port Orange, Florida, United States
Pain and Rehabilitation Clinic of Chicago
🇺🇸Chicago, Illinois, United States
Louisiana Research Associates, Inc.
🇺🇸New Orleans, Louisiana, United States
Commonwealth Biomedical Research, LLC
🇺🇸Madisonville, Kentucky, United States
Best Clinical Trials, LLC
🇺🇸New Orleans, Louisiana, United States
New Orleans Clinical Trial Management Inc.
🇺🇸Metairie, Louisiana, United States
HealthCare Research
🇺🇸St Louis, Missouri, United States
Research Center of Louisiana
🇺🇸New Orleans, Louisiana, United States
Medex Healthcare Research, Inc.
🇺🇸St Louis, Missouri, United States
Lake Michigan Clinical Research & Consulting, Inc.
🇺🇸Saint Joseph, Michigan, United States
Lovelace Scientific Resources
🇺🇸Henderson, Nevada, United States
Pain and Orthopedic Neurology , Charlotte Spine Center,
🇺🇸Charlotte, North Carolina, United States
Research Across America
🇺🇸New York, New York, United States
Metrolina Medical Research
🇺🇸Charlotte, North Carolina, United States
Pharmquest
🇺🇸Greensboro, North Carolina, United States
Center for Clinical Research
🇺🇸Winston Salem, North Carolina, United States
MedArk Clinical Research
🇺🇸Morgantown, North Carolina, United States
Keystone Clinical Research
🇺🇸Altoona, Pennsylvania, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Meridian Clinical Research, LLC
🇺🇸Omaha, Nebraska, United States
Arthritis & Osteoporosis Center
🇺🇸Orangeburg, South Carolina, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States
Advanced Clinical Therapeutics
🇺🇸Tuscon, Arizona, United States
Future Care Studies
🇺🇸Springfield, Massachusetts, United States
Dean Medical Center
🇺🇸Oregon, Wisconsin, United States
Brown Clinic
🇺🇸Watertown, South Dakota, United States
Radiant Research
🇺🇸Phoenix, Arizona, United States