Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
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
1 other identifier
interventional
567
1 country
87
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 chronic-pain
Started Sep 2007
Typical duration for phase_3 chronic-pain
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 17, 2007
CompletedFirst Posted
Study publicly available on registry
September 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
September 21, 2010
CompletedSeptember 10, 2012
September 1, 2012
1.6 years
September 17, 2007
July 28, 2010
September 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
"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)
Secondary Outcomes (2)
Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.
10 weeks
Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.
Weeks 4, 8, and 12 of the double-bind phase
Study Arms (2)
1
EXPERIMENTALBuprenorphine transdermal system 10 and 20 applied for 7-day wear
2
PLACEBO COMPARATORPlacebo transdermal system to match BTDS patches, applied for 7-day wear
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (87)
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Radiant Research, Phoenix Southeast
Chandler, Arizona, 85225, United States
Arizona Research Center, Inc.
Phoenix, Arizona, 85023, United States
Research Facility
Phoenix, Arizona, 85029, United States
Research Facility
Phoenix, Arizona, 85032, United States
Research Facility
Anaheim, California, 92801, United States
Lovelace Scientific Resources, Inc.
Beverly Hills, California, 90211, United States
Catalina Research Institute
Chino, California, 91710, United States
Research Facility
Downey, California, 90241, United States
Research Facility
Foothill Ranch, California, 92610, United States
Research Facility
Laguna Hills, California, 92653, United States
Research Facility
Sacramento, California, 95831, United States
Research Facility
Littleton, Colorado, 80128, United States
Research Facility
Stamford, Connecticut, 06905, United States
Coastal Pain Management
Bradenton, Florida, 34209, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Research Facility
Clearwater, Florida, 33765, United States
Research Facility
Jupiter, Florida, 33458-7200, United States
Research Facility
Largo, Florida, 33765, United States
Pharmax Research Clinic
Miami, Florida, 33126, United States
Research Facility
Miami, Florida, 33135, United States
Research Facility
Orlando, Florida, 32806, United States
Research Facility
Plantation, Florida, 33324, United States
Research Facility
Royal Palm Hammock, Florida, 33411, United States
Clinical Research of West Flor
Tampa, Florida, 33603, United States
Research Facility
Tampa, Florida, 33613, United States
Research Facility
Venice, Florida, 34292, United States
Research Facility
West Palm Beach, Florida, 33409, United States
Research Facility
Atlanta, Georgia, 30342, United States
Research Facility
Augusta, Georgia, 30901, United States
AMR Research Associates
Bogart, Georgia, 30622-6821, United States
Research Facility
Dawsonville, Georgia, 30534, United States
Research Facility
Decatur, Georgia, 30033, United States
Research Facility
Marietta, Georgia, 30066, United States
Research Facility
Honolulu, Hawaii, 96814-4526, United States
Rehabilitation Association of IN
Indianapolis, Indiana, 46250, United States
Research Facility
Overland Park, Kansas, 66211, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Stat-Lab I, Inc.
Baton Rouge, Louisiana, 70808, United States
Research Facility
New Iberia, Louisiana, 70563, United States
Research Facility
New Orleans, Louisiana, 70114, United States
Research Facility
Frederick, Maryland, 21702, United States
Research Facility
Brockton, Massachusetts, 02301, United States
East Coast Clinical Research
Haverhill, Massachusetts, 01830-6141, United States
Research Facility
Springfield, Massachusetts, 01103, United States
Research Facility
Bay City, Michigan, 48706, United States
Premier Internal Medicine
Biloxi, Mississippi, 39531, United States
Research Facility
Florissant, Missouri, 63031, United States
Research Facility
St Louis, Missouri, 63117, United States
Sports Med Consultants PC
St Louis, Missouri, 63141, United States
Research Facility
Henderson, Nevada, 89014, United States
Research Facility
New York, New York, 10004, United States
Research Facility
New York, New York, 10022, United States
Research Facility
Morgantown, North Carolina, 28655, United States
Research Facility
Winston-Salem, North Carolina, 27103, United States
Research Facility
Canton, Ohio, 44718, United States
Research Facility
Cincinnati, Ohio, 45242, United States
Research Facility
Columbus, Ohio, 43213, United States
Research Facility
Columbus, Ohio, 43235, United States
Digestive Endoscopy Center
Dayton, Ohio, 45415, United States
Research Facility
Dayton, Ohio, 45432, United States
Research Facility
Middleburg Heights, Ohio, 44130, United States
Research Facility
Mount Gilead, Ohio, 43338, United States
Research Facility
Toledo, Ohio, 43623, United States
Research Facility
Oklahoma City, Oklahoma, 73109, United States
Research Facility
Eugene, Oregon, 97404, United States
Research Facility
Medford, Oregon, 97504-8311, United States
Paramount Clinical Research
Bridgeville, Pennsylvania, 15017, United States
Research Facility
Duncansville, Pennsylvania, 16635, United States
Oyster Point Family Health Ctr
Lancaster, Pennsylvania, 17601, United States
Research Facility
Mechanicsburg, Pennsylvania, 17055, United States
Research Facility
West Reading, Pennsylvania, 19611, United States
New England Center for Clinical Research
Cranston, Rhode Island, 02920, United States
Research Facility
Cranston, Rhode Island, 02920, United States
Greenville Pharmaceutical Research
Greenville, South Carolina, 29415, United States
Arthritis Clinic, PLLC
Jackson, Tennessee, 38305, United States
Research Facility
Austin, Texas, 78756, United States
Research Facility
Colleyville, Texas, 76034, United States
Research Facility
Dallas, Texas, 75230, United States
Research Facility
Nederland, Texas, 77627, United States
Research Facility
San Antonio, Texas, 78205-1116, United States
Research Facility
San Antonio, Texas, 78229, United States
Research Facility
Sugarland, Texas, 77479, United States
Research Facility
Salt Lake City, Utah, 84102, United States
NDC Medical Center
Norfolk, Virginia, 23502, United States
Independence Family Medicine
Virginia Beach, Virginia, 23455, United States
Pacific Northwest Primary Care
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Leader, Executive Medical Director
- Organization
- Purdue Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2007
First Posted
September 18, 2007
Study Start
September 1, 2007
Primary Completion
April 1, 2009
Study Completion
November 1, 2009
Last Updated
September 10, 2012
Results First Posted
September 21, 2010
Record last verified: 2012-09