Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly
An Open, Randomised, Multicentre Study to Compare Buprenorphine Transdermal Delivery System (BTDS) With Standard Treatment in Elderly Subjects With OA of the Hip and/or Knee
2 other identifiers
interventional
219
1 country
1
Brief Summary
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 9, 2006
CompletedFirst Posted
Study publicly available on registry
May 10, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
March 30, 2010
CompletedJune 14, 2011
June 1, 2011
May 9, 2006
July 17, 2009
June 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Daily Pain Scores - BS11 Pain Scores.
The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.
every day over a 12 week study duration.
Study Arms (2)
buprenorphine transdermal system
EXPERIMENTALBuprenorphine transdermal 7 day analgesic patch
codeine paracetamol tablets
ACTIVE COMPARATORcodeine paracetamol combination tablets
Interventions
buprenorphine transdermal system 5, 10 and 20 mg
combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
Eligibility Criteria
You may qualify if:
- Either sex aged 65 or above
- Diagnosis of OA of the hip and/or knee
- Severe pain requiring step two medication
- Taking maximum dose of paracetamol
You may not qualify if:
- Painful disease of the joints other than OA
- Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS)
- Subjects taking cyclooxygenase (COX) II selective inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Napp Pharmaceuticals Ltd
Cambridge, CB4 0GW, United Kingdom
Related Publications (1)
Conaghan PG, O'Brien CM, Wilson M, Schofield JP. Transdermal buprenorphine plus oral paracetamol vs an oral codeine-paracetamol combination for osteoarthritis of hip and/or knee: a randomised trial. Osteoarthritis Cartilage. 2011 Aug;19(8):930-8. doi: 10.1016/j.joca.2011.03.011. Epub 2011 Apr 6.
PMID: 21477658DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Paul Schofield, Medical Director
- Organization
- Napp Pharmaceutical Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
Prof Philip Conaghan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 9, 2006
First Posted
May 10, 2006
Study Start
March 1, 2006
Study Completion
December 1, 2007
Last Updated
June 14, 2011
Results First Posted
March 30, 2010
Record last verified: 2011-06