Low Back Pain Clinical Trial
Official title:
Multi-center, Randomized, Double-blind, Placebo-controlled With Open Label run-in Study Assessing Efficacy, Tolerability, Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects With Moderate to Severe, Chronic Low Back Pain
| Verified date | September 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 determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.
| Status | Completed |
| Enrollment | 539 |
| Est. completion date | October 2008 |
| Est. primary completion date | July 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening, - Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of <5 mg oxycodone (or equivalent) per day, - Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy Exclusion Criteria: - Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period, - Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids, - Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives. Other protocol-specific inclusion/exclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Lovelace Scientific Resources | Albuquerque | New Mexico |
| United States | Research Facility | Altoona | Pennsylvania |
| United States | Research Facility | Anaheim | California |
| United States | Anderson Family Care, PA | Anderson | South Carolina |
| United States | Research Facility | Anniston | Alabama |
| United States | Independent Neurodiagnostic Clinic | Atlanta | Georgia |
| United States | Dolby Research, LLC | Baton Rouge | Louisiana |
| United States | Research Facility | Bay City | Michigan |
| United States | Lovelace Scientific Resources, Inc. | Beverly Hills | California |
| United States | Research Facility | Biloxi | Mississippi |
| United States | Research Facility | Boise | Idaho |
| United States | Research Facility | Brockton | Massachusetts |
| United States | Research Facility | Carmichael | California |
| United States | Radiant Research; Phoenix Southeast | Chandler | Arizona |
| United States | Research Facility | Charlotte | North Carolina |
| United States | Research Facility | Chicora | Pennsylvania |
| United States | Community Research | Cincinatti | Ohio |
| United States | Research Facility | Cincinnati | Ohio |
| United States | Advance Care Medical Group | City of Industry | California |
| United States | Clinical Research of West Florida | Clearwater | Florida |
| United States | Research Facility | Clearwater | Florida |
| United States | Research Facility | Columbus | Ohio |
| United States | Research Facility | Columbus | Ohio |
| United States | New England Center for Clinical Research | Cranston | Rhode Island |
| United States | KRK Medical Research | Dallas | Texas |
| United States | Research Facility | Dawsonville | Georgia |
| United States | Druid Oaks Health Center | Decatur | Georgia |
| United States | University Clinical Research | Deland | Florida |
| United States | Arthritis Associates of S. FL | Delray Beach | Florida |
| United States | Research Facility | Downey | California |
| United States | Research Facility | Duncansville | Pennsylvania |
| United States | Research Facility | Eugene | Oregon |
| United States | Research Facility | Florissant | Missouri |
| United States | Research Facility | Foothill Ranch | California |
| United States | Research Facility | Ft. Myers | Florida |
| United States | Research Facility | Greensboro | North Carolina |
| United States | East Coast Clinical Research | Haverhill | Massachusetts |
| United States | Research Facility | Henderson | Nevada |
| United States | Century Clinical Research, Inc. | Holly Hill | Florida |
| United States | Research Facility | Honolulu | Hawaii |
| United States | Rehabilitation Association of IN | Indianapolis | Indiana |
| United States | Research Facility | Jupiter | Florida |
| United States | Research Facility | Killeen | Texas |
| United States | Research Facility | Largo | Florida |
| United States | Research Facility | Las Vegas | Nevada |
| United States | Research Facility | Littleton | Colorado |
| United States | Research Facility | Marietta | Georgia |
| United States | Research Facility | Marietta | Georgia |
| United States | Research Facility | Mechanicsburg | Pennsylvania |
| United States | Research Facility | Medford | Oregon |
| United States | Research Facility | Merritt Island | Florida |
| United States | Pharmax Research Clinic | Miami | Florida |
| United States | Coastal Clinical Research, Inc. | Mobile | Alabama |
| United States | Research Facility | Morgantown | North Carolina |
| United States | Research Facility | New Orleans | Louisiana |
| United States | Research Facility | New Orleans | Louisiana |
| United States | Research Facility | New York | New York |
| United States | Research Facility | New York | New York |
| United States | Research Facility | Oklahoma City | Oklahoma |
| United States | Research Facility | Orlando | Florida |
| United States | Research Facility | Overland Park | Kansas |
| United States | Arizona Research Center Inc. | Phoenix | Arizona |
| United States | Research Facility | Phoenix | Arizona |
| United States | Research Facility | Phoenix | Arizona |
| United States | Research Facility | Plano | Texas |
| United States | Research Facility | Plantation | Florida |
| United States | Research Facility | Port Orange | Florida |
| United States | CTT Consultants, Inc. | Prairie Village | Kansas |
| United States | Research Facility | Roanoke | Virginia |
| United States | Research Facility | Sacramento | California |
| United States | Research Facility | Salt Lake City | Utah |
| United States | Research Facility | San Antonio | Texas |
| United States | Research Facility | San Antonio | Texas |
| United States | Research Facility | San Luis Obispo | California |
| United States | Research Facility | Shreveport | Louisiana |
| United States | Research Facility | Springfield | Massachusetts |
| United States | Research Facility | St. Louis | Missouri |
| United States | Research Facility | St. Louis | Missouri |
| United States | Sports Med Consultants, PC | St. Louis | Missouri |
| United States | Research Facility | Stamford | Connecticut |
| United States | Research Facility | Sugarland | Texas |
| United States | Clinical Research of West Flor | Tampa | Florida |
| United States | Research Facility | Tampa | Florida |
| United States | Research Facility | Toledo | Ohio |
| United States | Research Facility | West Palm Beach | Florida |
| United States | Research Facility | West Reading | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Purdue Pharma LP |
United States,
Steiner DJ, Sitar S, Wen W, Sawyerr G, Munera C, Ripa SR, Landau C. Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naïve patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placeb — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase. | Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine. | Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase. | No |
| Secondary | The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase | Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen. | weeks 2-12 | No |
| Secondary | The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase | The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 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 double-blind phase | No |
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