Back to resultsBuprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
Primary Purpose
Chronic Pain, Osteoarthritis of the Knee
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain,, OA of the knee,, opioid,, transdermal
Eligibility Criteria
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.
Sites / Locations
- Coastal Clinical Research, Inc.
- Radiant Research, Phoenix Southeast
- Arizona Research Center, Inc.
- Research Facility
- Research Facility
- Research Facility
- Lovelace Scientific Resources, Inc.
- Catalina Research Institute
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Coastal Pain Management
- Clinical Research of West Florida
- Research Facility
- Research Facility
- Research Facility
- Pharmax Research Clinic
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Clinical Research of West Flor
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- AMR Research Associates
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Rehabilitation Association of IN
- Research Facility
- Graves-Gilbert Clinic
- Stat-Lab I, Inc.
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- East Coast Clinical Research
- Research Facility
- Research Facility
- Premier Internal Medicine
- Research Facility
- Research Facility
- Sports Med Consultants PC
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Digestive Endoscopy Center
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Paramount Clinical Research
- Research Facility
- Oyster Point Family Health Ctr
- Research Facility
- Research Facility
- New England Center for Clinical Research
- Research Facility
- Greenville Pharmaceutical Research
- Arthritis Clinic, PLLC
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- NDC Medical Center
- Independence Family Medicine
- Pacific Northwest Primary Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Buprenorphine transdermal system 10 and 20 applied for 7-day wear
Placebo transdermal system to match BTDS patches, applied for 7-day wear
Outcomes
Primary Outcome Measures
"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.
Secondary Outcome Measures
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00531427
Brief Title
Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Purdue Pharma LP
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Osteoarthritis of the Knee
Keywords
Chronic pain,, OA of the knee,, opioid,, transdermal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
567 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Buprenorphine transdermal system 10 and 20 applied for 7-day wear
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo transdermal system to match BTDS patches, applied for 7-day wear
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Description
transdermal system 10 and 20 applied for 7-day wear
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
transdermal system (placebo) applied for 7-day wear
Primary Outcome Measure Information:
Title
"Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase.
Description
"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.
Time Frame
24 hours (week 12)
Secondary Outcome Measure Information:
Title
Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.
Description
Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen).
Time Frame
10 weeks
Title
Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.
Description
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.
Time Frame
Weeks 4, 8, and 12 of the double-bind phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Radiant Research, Phoenix Southeast
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Arizona Research Center, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Research Facility
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
Research Facility
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Research Facility
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Catalina Research Institute
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Research Facility
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Research Facility
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Facility Name
Research Facility
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Research Facility
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
Facility Name
Research Facility
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80128
Country
United States
Facility Name
Research Facility
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Coastal Pain Management
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Research Facility
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Research Facility
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458-7200
Country
United States
Facility Name
Research Facility
City
Largo
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Pharmax Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Research Facility
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Research Facility
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Research Facility
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Research Facility
City
Royal Palm
State/Province
Florida
ZIP/Postal Code
33411
Country
United States
Facility Name
Clinical Research of West Flor
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Research Facility
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Research Facility
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Research Facility
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Research Facility
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Research Facility
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
AMR Research Associates
City
Bogart
State/Province
Georgia
ZIP/Postal Code
30622-6821
Country
United States
Facility Name
Research Facility
City
Dawsonville
State/Province
Georgia
ZIP/Postal Code
30534
Country
United States
Facility Name
Research Facility
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Research Facility
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
Research Facility
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814-4526
Country
United States
Facility Name
Rehabilitation Association of IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Research Facility
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Graves-Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Stat-Lab I, Inc.
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Research Facility
City
New Iberia
State/Province
Louisiana
ZIP/Postal Code
70563
Country
United States
Facility Name
Research Facility
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Research Facility
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Research Facility
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
East Coast Clinical Research
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830-6141
Country
United States
Facility Name
Research Facility
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Research Facility
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Premier Internal Medicine
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Research Facility
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Research Facility
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Sports Med Consultants PC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Facility
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Research Facility
City
New York
State/Province
New York
ZIP/Postal Code
10004
Country
United States
Facility Name
Research Facility
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Research Facility
City
Morgantown
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Research Facility
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Facility
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Research Facility
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Research Facility
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Research Facility
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Digestive Endoscopy Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Research Facility
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Research Facility
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Research Facility
City
Mt. Gilead
State/Province
Ohio
ZIP/Postal Code
43338
Country
United States
Facility Name
Research Facility
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Research Facility
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Research Facility
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Research Facility
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504-8311
Country
United States
Facility Name
Paramount Clinical Research
City
Bridgeville
State/Province
Pennsylvania
ZIP/Postal Code
15017
Country
United States
Facility Name
Research Facility
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Oyster Point Family Health Ctr
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Research Facility
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
Research Facility
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
New England Center for Clinical Research
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Research Facility
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Greenville Pharmaceutical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29415
Country
United States
Facility Name
Arthritis Clinic, PLLC
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Research Facility
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Research Facility
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Research Facility
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Research Facility
City
Nederland
State/Province
Texas
ZIP/Postal Code
77627
Country
United States
Facility Name
Research Facility
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205-1116
Country
United States
Facility Name
Research Facility
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Facility
City
Sugarland
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Research Facility
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
NDC Medical Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Independence Family Medicine
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
Facility Name
Pacific Northwest Primary Care
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Links:
URL
http://app.purduepharma.com/xmlpublishing/pi.aspx?id=b
Description
Product Information
Learn more about this trial
Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
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