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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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buprenorphine transdermal system

Buprenorphine transdermal 7 day analgesic patch

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

buprenorphine transdermal system 5, 10 and 20 mg

codeine paracetamol tablets

codeine paracetamol combination tablets

Group Type ACTIVE_COMPARATOR

Codeine paracetamol

Intervention Type 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

Interventions

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Buprenorphine

buprenorphine transdermal system 5, 10 and 20 mg

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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BuTrans/Norspan Co-codamol tablets

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No