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| Sponsor: | Purdue Pharma LP |
|---|---|
| Information provided by: | Purdue Pharma LP |
| ClinicalTrials.gov Identifier: | NCT00313014 |
Purpose
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20mg) in comparison to the buprenorphine transdermal system (5mg) 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Low Back Pain |
Drug: Buprenorphine transdermal delivery system |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Multicenter, Randomized, Double-Blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain |
| Estimated Enrollment: | 891 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | September 2005 |
Buprenorphine is a synthetic opioid analgesic with over twenty-five 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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Birmingham Pain Center | |
| Birmingham, Alabama, United States, 35244 | |
| Winston Physician Services, LLC | |
| Haleyville, Alabama, United States, 35565 | |
| Arthritis Clinical Intervention Program | |
| Birmingham, Alabama, United States, 35249 | |
| United States, Arizona | |
| Arizona Research Center, Inc. | |
| Phoenix, Arizona, United States, 85023 | |
| Radiant Research | |
| Phoenix, Arizona, United States, 85029 | |
| Advanced Clinical Therapeutics | |
| Tuscon, Arizona, United States, 85712 | |
| United States, Arkansas | |
| Hot Springs Pain Clinic | |
| Hot Springs, Arkansas, United States, 71913 | |
| United States, California | |
| Shreenath Clinical Service | |
| Fountain Valley, California, United States, 92708 | |
| NuLife Clinical Research, Inc. | |
| Anaheim, California, United States, 92805 | |
| International Clinical Research Network | |
| Chula Vista, California, United States, 91911 | |
| Accelovance | |
| San Diego, California, United States, 92108 | |
| Lovelace Scientific Resources, Inc. | |
| Beverly Hills, California, United States, 90211 | |
| U of Calif at Davis, Med Ctr, Pain Management Center | |
| Sacramento, California, United States, 95817 | |
| Northern California Research Corp | |
| Carmichael, California, United States, 95608 | |
| United States, Colorado | |
| Southern Colorado Clinic | |
| Pueblo, Colorado, United States, 81008 | |
| United States, Florida | |
| Renstar Medical | |
| Ocala, Florida, United States, 34471 | |
| University Clinical Research, Inc. | |
| Deland, Florida, United States, 32720 | |
| Gold Coast Research, LLC | |
| Plantation, Florida, United States, 33324 | |
| The Arthritis Center | |
| Palm Harbor, Florida, United States, 34684 | |
| Palm Beach Research Center | |
| West Palm Beach, Florida, United States, 33409 | |
| University Clinical Research, Inc. | |
| Pembroke Pines, Florida, United States, 33024 | |
| Drug Study Institute | |
| Jupiter, Florida, United States, 33458 | |
| Peninsula Research Inc. | |
| Ormond Beach, Florida, United States, 32174 | |
| Innovative Research of West Florida, Inc. | |
| Largo, Florida, United States, 33770 | |
| Chiefland Medical Center | |
| Chiefland, Florida, United States, 32626 | |
| Coastal Medical Research | |
| Port Orange, Florida, United States, 32168 | |
| United States, Georgia | |
| Georgia Medical Research Institute | |
| Marietta, Georgia, United States, 30060 | |
| Atlanta Knee & Shoulder Clinic | |
| Stockbridge, Georgia, United States, 30281 | |
| United States, Idaho | |
| Pain Care Boise | |
| Boise, Idaho, United States, 83702 | |
| Idaho Arthritis and Osteoporosis Center | |
| Meridian, Idaho, United States, 83742 | |
| United States, Illinois | |
| Pain and Rehabilitation Clinic of Chicago | |
| Chicago, Illinois, United States, 60610 | |
| United States, Indiana | |
| MediSphere Medical Research Center, LLC | |
| Evansville, Indiana, United States, 47714 | |
| GFI Research Center | |
| Evansville, Indiana, United States, 47714 | |
| United States, Iowa | |
| Medical Associates Clinics | |
| Dubuque, Iowa, United States, 52002 | |
| United States, Kansas | |
| Vince and Associates Clinical Research | |
| Overland Park, Kansas, United States, 66211 | |
| CTT, Inc. | |
| Prairie Village, Kansas, United States, 66206 | |
| United States, Kentucky | |
| Commonwealth Biomedical Research, LLC | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Louisiana | |
| Louisiana Research Associates, Inc. | |
| New Orleans, Louisiana, United States, 70114 | |
| New Orleans Clinical Trial Management Inc. | |
| Metairie, Louisiana, United States, 70006 | |
| Research Center of Louisiana | |
| New Orleans, Louisiana, United States, 70115 | |
| Best Clinical Trials, LLC | |
| New Orleans, Louisiana, United States, 70115 | |
| United States, Maryland | |
| Sinai Hospital of Baltimore | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Massachusetts | |
| Future Care Studies | |
| Springfield, Massachusetts, United States, 11070 | |
| United States, Michigan | |
| Lake Michigan Clinical Research & Consulting, Inc. | |
| Saint Joseph, Michigan, United States, 49085 | |
| Rheumatology PC | |
| Kalamazoo, Michigan, United States, 49009 | |
| United States, Missouri | |
| HealthCare Research | |
| St Louis, Missouri, United States, 63141 | |
| Medex Healthcare Research, Inc. | |
| St Louis, Missouri, United States, 63108 | |
| United States, Nebraska | |
| Meridian Clinical Research, LLC | |
| Omaha, Nebraska, United States, 68134 | |
| United States, Nevada | |
| Lovelace Scientific Resources | |
| Henderson, Nevada, United States, 89014 | |
| Pivotal Research Centers | |
| North Las Vegas, Nevada, United States, 89030 | |
| United States, New York | |
| Research Across America | |
| New York, New York, United States, 10022 | |
| United States, North Carolina | |
| MedArk Clinical Research | |
| Morgantown, North Carolina, United States, 28655 | |
| Wake Research Associates, LLC | |
| Raleigh, North Carolina, United States, 27612 | |
| Triangle Orthopaedic Associates | |
| Durham, North Carolina, United States, 27704 | |
| Pharmquest | |
| Greensboro, North Carolina, United States, 27401 | |
| Metrolina Medical Research | |
| Charlotte, North Carolina, United States, 28209 | |
| Center for Clinical Research | |
| Winston Salem, North Carolina, United States, 27103 | |
| Pain and Orthopedic Neurology , Charlotte Spine Center, | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, North Dakota | |
| Odyssey Research | |
| Bismark, North Dakota, United States, 58502 | |
| United States, Oklahoma | |
| COR Clinical Research, LLC | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Associated Medical Services | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Pennsylvania | |
| Keystone Clinical Research | |
| Altoona, Pennsylvania, United States, 16602 | |
| University Orthopedics Center | |
| State College, Pennsylvania, United States, 16801 | |
| Central Pennsylvania Clinical Research | |
| Mechanicsburg, Pennsylvania, United States, 17055 | |
| Valley Pain Specialists | |
| Bethlehem, Pennsylvania, United States, 18016 | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| BioMedical Research Associates | |
| Shippensburg, Pennsylvania, United States, 17257 | |
| United States, Rhode Island | |
| Omega Medical Research | |
| Warwick, Rhode Island, United States, 28860 | |
| New England Center Clinical Research | |
| Cranston, Rhode Island, United States, 29200 | |
| United States, South Carolina | |
| Arthritis & Osteoporosis Center | |
| Orangeburg, South Carolina, United States, 29118 | |
| United States, South Dakota | |
| Brown Clinic | |
| Watertown, South Dakota, United States, 57201 | |
| United States, Tennessee | |
| Holston Medical Group | |
| Kingsport, Tennessee, United States, 37660 | |
| Tri Cities Medical Research | |
| Bristol, Tennessee, United States, 37620 | |
| Holston Medical Group | |
| Bristol, Tennessee, United States, 37620 | |
| United States, Texas | |
| N. Texas Neuro Research | |
| Wichita Falls, Texas, United States, 76301 | |
| Galenos Research | |
| Dallas, Texas, United States, 75251 | |
| Clinical Trial Network Oaks Medical Center | |
| Spring, Texas, United States, 77386 | |
| Unlimited Research | |
| San Antonio, Texas, United States, 78233 | |
| Benchmark Research | |
| San Angelo, Texas, United States, 76904 | |
| KRK Medical Research | |
| Richardson, Texas, United States, 75080 | |
| Texas Medical Research Associates | |
| San Antonio, Texas, United States, 78238 | |
| Team Research of Central Texas | |
| Harker Heights, Texas, United States, 76548 | |
| Benchmark Research | |
| Fort Worth, Texas, United States, 76135 | |
| United States, Utah | |
| Lifetree Clinical Research | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Wisconsin | |
| Dean Medical Center | |
| Oregon, Wisconsin, United States, 53575 | |
More Information
| Study ID Numbers: | BUP3015 |
| Study First Received: | April 10, 2006 |
| Last Updated: | April 29, 2006 |
| ClinicalTrials.gov Identifier: | NCT00313014 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Low back pain opioid transdermal |
|
Narcotic Antagonists Nervous System Diseases Physiological Effects of Drugs Central Nervous System Depressants Low Back Pain Narcotics Pain Back Pain Pharmacologic Actions |
Signs and Symptoms Buprenorphine Sensory System Agents Therapeutic Uses Neurologic Manifestations Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |
