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

Napp Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Drug: Codeine paracetamol; Drug: Buprenorphine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00324038

BUP4004

2005-004279-39

Details and patient eligibility

About

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

Enrollment: 219 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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219 participants in 2 patient groups

buprenorphine transdermal system

Experimental group

Description:

Buprenorphine transdermal 7 day analgesic patch

Treatment:

Drug: Buprenorphine

codeine paracetamol tablets

Active Comparator group

Description:

codeine paracetamol combination tablets

Treatment:

Drug: Codeine paracetamol