Chronic Pain Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee
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 pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization 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 | 567 |
Est. completion date | November 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition, - clinical diagnosis of OA of the knee 1 year or longer, - 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 OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy. Exclusion Criteria: - subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study, - subjects who are allergic to buprenorphine or who have 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 | Research Facility | Anaheim | California |
United States | Research Facility | Atlanta | Georgia |
United States | Research Facility | Augusta | Georgia |
United States | Research Facility | Austin | Texas |
United States | Stat-Lab I, Inc. | Baton Rouge | Louisiana |
United States | Research Facility | Bay City | Michigan |
United States | Lovelace Scientific Resources, Inc. | Beverly Hills | California |
United States | Premier Internal Medicine | Biloxi | Mississippi |
United States | AMR Research Associates | Bogart | Georgia |
United States | Graves-Gilbert Clinic | Bowling Green | Kentucky |
United States | Coastal Pain Management | Bradenton | Florida |
United States | Paramount Clinical Research | Bridgeville | Pennsylvania |
United States | Research Facility | Brockton | Massachusetts |
United States | Research Facility | Canton | Ohio |
United States | Radiant Research, Phoenix Southeast | Chandler | Arizona |
United States | Catalina Research Institute | Chino | California |
United States | Research Facility | Cincinnati | Ohio |
United States | Clinical Research of West Florida | Clearwater | Florida |
United States | Research Facility | Clearwater | Florida |
United States | Research Facility | Colleyville | Texas |
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 | Research Facility | Cranston | Rhode Island |
United States | Research Facility | Dallas | Texas |
United States | Research Facility | Dawsonville | Georgia |
United States | Digestive Endoscopy Center | Dayton | Ohio |
United States | Research Facility | Dayton | Ohio |
United States | Research Facility | Decatur | Georgia |
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 | Frederick | Maryland |
United States | Greenville Pharmaceutical Research | Greenville | South Carolina |
United States | East Coast Clinical Research | Haverhill | Massachusetts |
United States | Research Facility | Henderson | Nevada |
United States | Research Facility | Honolulu | Hawaii |
United States | Rehabilitation Association of IN | Indianapolis | Indiana |
United States | Arthritis Clinic, PLLC | Jackson | Tennessee |
United States | Research Facility | Jupiter | Florida |
United States | Research Facility | Laguna Hills | California |
United States | Oyster Point Family Health Ctr | Lancaster | Pennsylvania |
United States | Research Facility | Largo | Florida |
United States | Research Facility | Littleton | Colorado |
United States | Research Facility | Marietta | Georgia |
United States | Research Facility | Mechanicsburg | Pennsylvania |
United States | Research Facility | Medford | Oregon |
United States | Pharmax Research Clinic | Miami | Florida |
United States | Research Facility | Miami | Florida |
United States | Research Facility | Middleburg Heights | Ohio |
United States | Coastal Clinical Research, Inc. | Mobile | Alabama |
United States | Research Facility | Morgantown | North Carolina |
United States | Research Facility | Mt. Gilead | Ohio |
United States | Research Facility | Nederland | Texas |
United States | Research Facility | New Iberia | 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 | NDC Medical Center | Norfolk | Virginia |
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 | Plantation | Florida |
United States | Research Facility | Royal Palm | Florida |
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 | Springfield | Massachusetts |
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 | Pacific Northwest Primary Care | Tacoma | Washington |
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 | Venice | Florida |
United States | Independence Family Medicine | Virginia Beach | Virginia |
United States | Research Facility | West Palm Beach | Florida |
United States | Research Facility | West Reading | Pennsylvania |
United States | Research Facility | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Purdue Pharma LP |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | "Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase. | "Average pain over the last 24 hours" scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily. | 24 hours (week 12) | No |
Secondary | Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase. | Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen). | 10 weeks | No |
Secondary | Sleep Disturbance Subscale of the 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 sleep 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 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. 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, and 12 of the double-bind phase | No |
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