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

Napp Pharmaceuticals Limited219 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

219

Conditions

Osteoarthritis

Interventions

BuprenorphineDRUG

buprenorphine transdermal system 5, 10 and 20 mg

Codeine paracetamolDRUG

combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Napp Pharmaceuticals Ltd

Cambridge, United Kingdom

Outcomes

Primary Outcomes

Average Daily Pain Scores - BS11 Pain Scores.

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.

Time frame: every day over a 12 week study duration.

Data from ClinicalTrials.gov

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