Back Pain Lower Back Chronic Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release Vs Buprenorphine Transdermal System (BTDS) 5 in Subjects With Moderate to Severe Low Back Pain: A 52-Week Open-label Extension Phase of BUP3015
| Verified date | August 2012 |
| Source | Purdue Pharma LP |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose [up to BTDS 20 micrograms (mcg) / hour (h)] depending on adequate pain relief and tolerability.
| Status | Terminated |
| Enrollment | 354 |
| Est. completion date | January 2008 |
| Est. primary completion date | September 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects who completed all visits of the double-blind phase on study drug, and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase. - For subjects entering the extension, 4 electrocardiograms (ECGs) are required at entry if none were collected prior to randomization while on BTDS 20. NOTE: Subjects with any 1 QT data corrected for heart rate using the Fridericia formula (QTcF) interval = 500 milliseconds (msec) would be discontinued from the extension phase Exclusion Criteria: - Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with a every (q) 24 hours (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Keystone Clinical Research | Altoona | Pennsylvania |
| United States | NuLife Clinical Research, Inc. | Anaheim | California |
| United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
| United States | Valley Pain Specialists | Bethlehem | Pennsylvania |
| United States | Lovelace Scientific Resources | Beverly Hills | California |
| United States | Arthritis Clinical Intervention Program | Birmingham | Alabama |
| United States | Birmingham Pain Center | Birmingham | Alabama |
| United States | Odyssey Research | Bismark | North Dakota |
| United States | Pain Care Boise | Boise | Idaho |
| United States | Holston Medical Group | Bristol | Tennessee |
| United States | Tri Cities Medical Research | Bristol | Tennessee |
| United States | Northern California Research Corp | Carmichael | California |
| United States | Metrolina Medical Research | Charlotte | North Carolina |
| United States | Pain and Orthopedic Neurology , Charlotte Spine Center, | Charlotte | North Carolina |
| United States | Pain and Rehabilitation Clinic of Chicago | Chicago | Illinois |
| United States | Chiefland Medical Center | Chiefland | Florida |
| United States | International Clinical Research Network | Chula Vista | California |
| United States | New England Center Clinical Research | Cranston | Rhode Island |
| United States | Galenos Research | Dallas | Texas |
| United States | University Clinical Research Deland | Deland | Florida |
| United States | Medical Associates Clinics | Dubuque | Iowa |
| United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
| United States | Triangle Orthopaedic Associates | Durham | North Carolina |
| United States | GFI Research Center | Evansville | Indiana |
| United States | MediSphere Medical Research Center, LLC | Evansville | Indiana |
| United States | Benchmark Research | Fort Worth | Texas |
| United States | Shreenath Clinical Service | Fountain Valley | California |
| United States | Pharmquest | Greensboro | North Carolina |
| United States | Winston Physician Services, Inc | Haleyville | Alabama |
| United States | Team Research of Central Texas | Harker Heights | Texas |
| United States | Lovelace Scientific Resources | Henderson | Nevada |
| United States | Hot Springs Pain Clinic | Hot Springs | Arkansas |
| United States | Drug Study Institute | Jupiter | Florida |
| United States | Rheumatology PC | Kalamazoo | Michigan |
| United States | Holston Medical Group | Kingsport | Tennessee |
| United States | Innovative Research of West Florida, Inc. | Largo | Florida |
| United States | Commonwealth Biomedical Research, LLC | Madisonville | Kentucky |
| United States | Georgia Medical Research Institute | Marietta | Georgia |
| United States | Central Pennsylvania Clinical Research | Mechanicsburg | Pennsylvania |
| United States | Idaho Arthritis and Osteoporosis Center | Meridian | Idaho |
| United States | New Orleans Clinical Trial Management Inc. | Metairie | Louisiana |
| United States | MedArk Clinical Research | Morgantown | North Carolina |
| United States | Best Clinical Trials, LLC | New Orleans | Louisiana |
| United States | Louisiana Research Associates, Inc. | New Orleans | Louisiana |
| United States | Research Center of Louisiana | New Orleans | Louisiana |
| United States | Research Across America | New York | New York |
| United States | Pivotal Research Centers | North Las Vegas | Nevada |
| United States | Renstar Medical | Ocala | Florida |
| United States | Associated Medical Services Inc | Oklahoma City | Oklahoma |
| United States | COR Clinical Research, LLC | Oklahoma City | Oklahoma |
| United States | Meridian Clinical Research, LLC | Omaha | Nebraska |
| United States | The Arthritis and Osteoporosis Center | Orangeburg | South Carolina |
| United States | Dean Medical Center | Oregon | Wisconsin |
| United States | Peninsula Research Inc. | Ormond Beach | Florida |
| United States | Vince and Associates Clinical Research | Overland Park | Kansas |
| United States | The Arthritis Center | Palm Harbor | Florida |
| United States | University Clinical Research, Inc. | Pembroke Pines | Florida |
| United States | Arizona Research Center Inc | Phoenix | Arizona |
| United States | Radiant Research | Phoenix | Arizona |
| United States | Gold Coast Research, LLC | Plantation | Florida |
| United States | CTT, Inc. | Prairie Village | Kansas |
| United States | Southern Colorado Clinic | Pueblo | Colorado |
| United States | Wake Research Associates, LLC | Raleigh | North Carolina |
| United States | KRK Medical Research | Richardson | Texas |
| United States | U of Calif at Davis, Med Ctr, Pain Management Center | Sacramento | California |
| United States | Lake Michigan Clinical Research & Consulting, Inc. | Saint Joseph | Michigan |
| United States | Lifetree Clinical Research | Salt Lake City | Utah |
| United States | Benchmark Research | San Angelo | Texas |
| United States | Texas Medical Research Associates | San Antonio | Texas |
| United States | Unlimited Research | San Antonio | Texas |
| United States | Accelovance | San Diego | California |
| United States | BioMedical Research Associates | Shippensburg | Pennsylvania |
| United States | Clinical Trial Network Oaks Medical Center | Spring | Texas |
| United States | Future Care Studies | Springfield | Massachusetts |
| United States | HealthCare Research | St Louis | Missouri |
| United States | Medex Healthcare Research Inc | St Louis | Missouri |
| United States | University Orthopedics Center | State College | Pennsylvania |
| United States | Atlanta Knee & Shoulder Clinic | Stockbridge | Georgia |
| United States | Advanced Clinical Therapeutics | Tucson | Arizona |
| United States | Omega Medical Research | Warwick | Rhode Island |
| United States | Brown Clinic | Watertown | South Dakota |
| United States | Palm Beach Research Center | West Palm Beach | Florida |
| United States | N. Texas Neuro Research | Wichita Falls | Texas |
| United States | Center for Clinical Research | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Purdue Pharma LP |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) as a Measure of Safety | The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015). | 52-week extension phase | Yes |
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