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

June 13, 2011 updated by: Napp Pharmaceuticals Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB4 0GW
        • Napp Pharmaceuticals Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: buprenorphine transdermal system
Buprenorphine transdermal 7 day analgesic patch
Drug: Buprenorphine
buprenorphine transdermal system 5, 10 and 20 mg
Other Names:
  • 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 Names:
  • Co-codamol tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every day over a 12 week study duration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Napp Pharmaceuticals Limited

Investigators

  • Principal Investigator: Prof Philip Conaghan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

May 9, 2006

First Submitted That Met QC Criteria

May 9, 2006

First Posted (Estimate)

May 10, 2006

Study Record Updates

Last Update Posted (Estimate)

June 14, 2011

Last Update Submitted That Met QC Criteria

June 13, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-004279-39
  • BUP4004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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