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Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly

This study has been completed.
Information provided by:
Napp Pharmaceuticals Limited Identifier:
First received: May 9, 2006
Last updated: June 13, 2011
Last verified: June 2011
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).

Condition Intervention Phase
Osteoarthritis Drug: Buprenorphine Drug: Codeine paracetamol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Napp Pharmaceuticals Limited:

Primary Outcome Measures:
  • Average Daily Pain Scores - BS11 Pain Scores. [ Time Frame: every day over a 12 week study duration. ]
    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.

Enrollment: 219
Study Start Date: March 2006
Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: buprenorphine transdermal system
Buprenorphine transdermal 7 day analgesic patch
Drug: Buprenorphine
buprenorphine transdermal system 5, 10 and 20 mg
Other Name: BuTrans/Norspan
Active Comparator: codeine paracetamol tablets
codeine paracetamol combination tablets
Drug: Codeine paracetamol
combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
Other Name: Co-codamol tablets


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00324038

United Kingdom
Napp Pharmaceuticals Ltd
Cambridge, United Kingdom, CB4 0GW
Sponsors and Collaborators
Napp Pharmaceuticals Limited
Principal Investigator: Prof Philip Conaghan
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr J Paul Schofield, Napp Pharmaceuticals Ltd Identifier: NCT00324038     History of Changes
Other Study ID Numbers: 2005-004279-39
Study First Received: May 9, 2006
Results First Received: July 17, 2009
Last Updated: June 13, 2011

Keywords provided by Napp Pharmaceuticals Limited:
OA of the hips and/or knees

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Analgesics, Non-Narcotic
Antitussive Agents
Respiratory System Agents processed this record on September 21, 2017