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 Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain
| 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 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.
| Status | Terminated |
| Enrollment | 660 |
| Est. completion date | September 2005 |
| Est. primary completion date | September 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), 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, Inc. | 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, Inc. | 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, LLC | 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 | Oklahoma City | Oklahoma |
| United States | COR Clinical Research, LLC | Oklahoma City | Oklahoma |
| United States | Meridian Clinical Research, LLC | Omaha | Nebraska |
| United States | Arthritis & 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 | Coastal Medical Research | Port Orange | 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 | Tuscon | 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,
Steiner D, Munera C, Hale M, Ripa S, Landau C. Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study. J Pain. 2011 Nov;12(11):1163-73. doi: 10.1016/j.jpain.2011.06.003 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | 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) | Last 24 hours score at weeks 4, 8, 12 of the double-blind phase | No |
| Secondary | Mean Daily Number of Supplemental Analgesic Tablets | The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase | Double-blind phase (84 days) | No |
| Secondary | Oswestry Disability Index (ODI) Score (V 2.0) | 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.) |
Weeks 4, 8, 12 | No |
| Secondary | The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12. | 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. |
Weeks 4, 8, 12 of the double-blind phase | No |
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