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OpenTrials
Completed

NCT Number: NCT00324038

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

The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Napp Pharmaceuticals Ltd

Cambridge, CB4 0GW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

buprenorphine transdermal system 5, 10 and 20 mg

Other names: BuTrans/Norspan

Codeine paracetamol

Drug

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 names: Co-codamol tablets

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Napp Pharmaceuticals Limited

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
May 10, 2006
Registry last updated
Jun 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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