Study Stopped
terminated early for administrative reasons unrelated to safety or efficacy
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain
Randomized, Double-blind, Multicenter Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release (OxyIR) Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain
1 other identifier
interventional
418
1 country
23
Brief Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) 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 P50-P75 for phase_3
Started Apr 2004
Shorter than P25 for phase_3
23 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
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 6, 2006
CompletedFirst Posted
Study publicly available on registry
April 7, 2006
CompletedResults Posted
Study results publicly available
September 15, 2010
CompletedSeptember 10, 2012
September 1, 2012
1.2 years
April 6, 2006
July 15, 2010
September 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
"Average Pain Over the Last 24 Hours" Scores at Weeks 4, 8, and 12 of the Double-blind Phase.
The "average pain over the last 24 hours" score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12).
Weeks 4, 8, and 12 of the double-blind phase
Secondary Outcomes (3)
The Mean Daily Number of Supplemental Analgesic Medication Tablets
Double-blind phase (84 days)
The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase
Weeks 4, 8 and 12 of the double-blind phase
The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
Weeks 4, 8, and 12 of the Double-blind Phase
Study Arms (3)
BTDS 5
ACTIVE COMPARATORBuprenorphine transdermal patch 5 mcg/h applied for 7-day wear
BTDS 20
EXPERIMENTALBuprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Oxycodone Immediate-Release (Oxy IR) 40 mg
EXPERIMENTALOxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Interventions
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Eligibility Criteria
You may qualify if:
- Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by radiographic evidence within the last 2 years.
- Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.
You may not qualify if:
- Not currently taking and tolerating opioids.
- 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 osteoarthritis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (23)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
International Clinical Research Network
Chula Vista, California, 91910, United States
Clinical Trials Research
Roseville, California, 95661, United States
Accelovance
San Diego, California, 92108, United States
Torrance Clinical Research
Torrance, California, 90505, United States
Southern Colorado Clinic
Pueblo, Colorado, 81008, United States
Drug Study Institute
Jupiter, Florida, 33458, United States
Innovative Research of West Florida, Inc.
Largo, Florida, 33770, United States
International Medical Research
Ormond Beach, Florida, 32174, United States
Peninsula Research, Inc.
Ormond Beach, Florida, 32174, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Georgia Medical Research Institute
Marietta, Georgia, 30060, United States
Non- Surgical Orthopedic & Spine Center, P.C.
Marietta, Georgia, 30060, United States
The Arthritis Center
Springfield, Illinois, 62704, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431, United States
Miray Medical Center
Brockton, Massachusetts, 23010, United States
Professional Clinical Research Crystal Lake Health Center
Benzonia, Michigan, 49616, United States
Rheumatology PC
Kalamazoo, Michigan, 49009, United States
Pharm Quest
Greensboro, North Carolina, 27401, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Amarillo Center for Clinical Research
Amarillo, Texas, 79124, United States
Med Search Professional Group/Pharmaceutical C-Trials Inc.
Hurst, Texas, 76054, United States
Texas Medical Research Associates
San Antonio, Texas, 78238, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early for administrative reasons not related to safety or efficacy. Low enrollment at termination led to reduced power.
Results Point of Contact
- Title
- Clinical Leader, Medical Director
- Organization
- Purdue Pharma L.P.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2006
First Posted
April 7, 2006
Study Start
April 1, 2004
Primary Completion
July 1, 2005
Study Completion
August 1, 2005
Last Updated
September 10, 2012
Results First Posted
September 15, 2010
Record last verified: 2012-09