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Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

Information source: Purdue Pharma LP
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Back Pain Lower Back Chronic

Intervention: Buprenorphine (Drug); Buprenorphine (Drug); Oxycodone Immediate-Release (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Purdue Pharma LP

Official(s) and/or principal investigator(s):
Martin Hale, MD, Principal Investigator, Affiliation: Gold Coast Research LLC, Weston, FL, USA


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.

Clinical Details

Official title: A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-release Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.

Secondary outcome:

Mean Daily Number of Supplemental Analgesic Tablets

Oswestry Disability Index (ODI) Score (V 2.0)

The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Exclusion Criteria:

- 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.

Locations and Contacts

Arthritis Clinical Intervention Program, Birmingham, Alabama 35249, United States

Birmingham Pain Center, Birmingham, Alabama 35244, United States

Winston Physician Services, LLC, Haleyville, Alabama 35565, United States

Arizona Research Center, Inc., Phoenix, Arizona 85023, United States

Radiant Research, Phoenix, Arizona 85029, United States

Advanced Clinical Therapeutics, Tuscon, Arizona 85712, United States

Hot Springs Pain Clinic, Hot Springs, Arkansas 71913, United States

NuLife Clinical Research, Inc., Anaheim, California 92805, United States

Lovelace Scientific Resources, Inc., Beverly Hills, California 90211, United States

Northern California Research Corp, Carmichael, California 95608, United States

International Clinical Research Network, Chula Vista, California 91911, United States

Shreenath Clinical Service, Fountain Valley, California 92708, United States

U of Calif at Davis, Med Ctr, Pain Management Center, Sacramento, California 95817, United States

Accelovance, San Diego, California 92108, United States

Southern Colorado Clinic, Pueblo, Colorado 81008, United States

Chiefland Medical Center, Chiefland, Florida 32626, United States

University Clinical Research, Inc., Deland, Florida 32720, United States

Drug Study Institute, Jupiter, Florida 33458, United States

Innovative Research of West Florida, Inc., Largo, Florida 33770, United States

Renstar Medical, Ocala, Florida 34471, United States

Peninsula Research Inc., Ormond Beach, Florida 32174, United States

The Arthritis Center, Palm Harbor, Florida 34684, United States

University Clinical Research, Inc., Pembroke Pines, Florida 33024, United States

Gold Coast Research, LLC, Plantation, Florida 33324, United States

Coastal Medical Research, Port Orange, Florida 32168, United States

Palm Beach Research Center, West Palm Beach, Florida 33409, United States

Georgia Medical Research Institute, Marietta, Georgia 30060, United States

Atlanta Knee & Shoulder Clinic, Stockbridge, Georgia 30281, United States

Pain Care Boise, Boise, Idaho 83702, United States

Idaho Arthritis and Osteoporosis Center, Meridian, Idaho 83742, United States

Pain and Rehabilitation Clinic of Chicago, Chicago, Illinois 60610, United States

GFI Research Center, Evansville, Indiana 47714, United States

MediSphere Medical Research Center, LLC, Evansville, Indiana 47714, United States

Medical Associates Clinics, Dubuque, Iowa 52002, United States

Vince and Associates Clinical Research, Overland Park, Kansas 66211, United States

CTT, Inc., Prairie Village, Kansas 66206, United States

Commonwealth Biomedical Research, LLC, Madisonville, Kentucky 42431, United States

New Orleans Clinical Trial Management Inc., Metairie, Louisiana 70006, United States

Best Clinical Trials, LLC, New Orleans, Louisiana 70115, United States

Louisiana Research Associates, Inc., New Orleans, Louisiana 70114, United States

Research Center of Louisiana, New Orleans, Louisiana 70115, United States

Sinai Hospital of Baltimore, Baltimore, Maryland 21215, United States

Future Care Studies, Springfield, Massachusetts 11070, United States

Rheumatology PC, Kalamazoo, Michigan 49009, United States

Lake Michigan Clinical Research & Consulting, Inc., Saint Joseph, Michigan 49085, United States

HealthCare Research, St Louis, Missouri 63141, United States

Medex Healthcare Research, Inc., St Louis, Missouri 63108, United States

Meridian Clinical Research, LLC, Omaha, Nebraska 68134, United States

Lovelace Scientific Resources, Henderson, Nevada 89014, United States

Pivotal Research Centers, North Las Vegas, Nevada 89030, United States

Research Across America, New York, New York 10022, United States

Metrolina Medical Research, Charlotte, North Carolina 28209, United States

Pain and Orthopedic Neurology , Charlotte Spine Center,, Charlotte, North Carolina 28207, United States

Triangle Orthopaedic Associates, Durham, North Carolina 27704, United States

Pharmquest, Greensboro, North Carolina 27401, United States

MedArk Clinical Research, Morgantown, North Carolina 28655, United States

Wake Research Associates, LLC, Raleigh, North Carolina 27612, United States

Center for Clinical Research, Winston Salem, North Carolina 27103, United States

Odyssey Research, Bismark, North Dakota 58502, United States

Associated Medical Services, Oklahoma City, Oklahoma 73112, United States

COR Clinical Research, LLC, Oklahoma City, Oklahoma 73103, United States

Keystone Clinical Research, Altoona, Pennsylvania 16602, United States

Valley Pain Specialists, Bethlehem, Pennsylvania 18016, United States

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States

Central Pennsylvania Clinical Research, Mechanicsburg, Pennsylvania 17055, United States

BioMedical Research Associates, Shippensburg, Pennsylvania 17257, United States

University Orthopedics Center, State College, Pennsylvania 16801, United States

New England Center Clinical Research, Cranston, Rhode Island 29200, United States

Omega Medical Research, Warwick, Rhode Island 28860, United States

Arthritis & Osteoporosis Center, Orangeburg, South Carolina 29118, United States

Brown Clinic, Watertown, South Dakota 57201, United States

Holston Medical Group, Bristol, Tennessee 37620, United States

Tri Cities Medical Research, Bristol, Tennessee 37620, United States

Holston Medical Group, Kingsport, Tennessee 37660, United States

Galenos Research, Dallas, Texas 75251, United States

Benchmark Research, Fort Worth, Texas 76135, United States

Team Research of Central Texas, Harker Heights, Texas 76548, United States

KRK Medical Research, Richardson, Texas 75080, United States

Benchmark Research, San Angelo, Texas 76904, United States

Texas Medical Research Associates, San Antonio, Texas 78238, United States

Unlimited Research, San Antonio, Texas 78233, United States

Clinical Trial Network Oaks Medical Center, Spring, Texas 77386, United States

N. Texas Neuro Research, Wichita Falls, Texas 76301, United States

Lifetree Clinical Research, Salt Lake City, Utah 84106, United States

Dean Medical Center, Oregon, Wisconsin 53575, United States

Additional Information

Product Information

Starting date: February 2004
Last updated: August 27, 2012

Page last updated: August 23, 2015

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