A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain
Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
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).