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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


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.


Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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