Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly
Information source: Napp Pharmaceuticals Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Buprenorphine (Drug); Codeine paracetamol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Napp Pharmaceuticals Limited Official(s) and/or principal investigator(s): Prof Philip Conaghan, Principal Investigator
Summary
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with
standard- treatment in subjects with osteoarthritis (OA).
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Average Daily Pain Scores - BS11 Pain Scores.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Napp Pharmaceuticals Ltd, Cambridge CB4 0GW, United Kingdom
Additional Information
Starting date: March 2006
Last updated: June 13, 2011
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