A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain

Summary

This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may receive duloxetine or placebo during the course of the trial. All subjects will, in fact, receive placebo for the first two weeks. All subjects will then be placed on 60-90mg per day of duloxetine. Primary outcome assessment will compare pain intensity at 2 weeks (after placebo) to that at 12 weeks (after 10 weeks of duloxetine treatment). Study Hypothesis: In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 60-90 mg Duloxetine per day over 10 weeks will provide significant additional pain relief over that achieved with placebo(\> 30% reduction after Duloxetine treatment).

Timeline

Start

2004-09

Primary completion

2007-02

Completion

2007-02

Drugs

Indications