drugset / Trial / NCT00611676

A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain

NCT00611676

Non-randomizedSingle-groupSingle-blindTreatment

Summary

This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may receive Venlafaxine 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 150-225 mg per day of venlafaxine. Primary outcome assessment will compare pain intensity at 2 weeks (after placebo) to that at 12 weeks (after 10 weeks of Venlafaxine treatment). Study Hypothesis: In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 150-225 mg Venlafaxine per day over 10 weeks will provide significant additional pain relief over that achieved with placebo (more than 30% reduction after Venlafaxine treatment).

Timeline

Start
2004-09
Primary completion
2007-02
Completion
2007-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Venlafaxine Small molecule 150 mg
Subject Venlafaxine Small molecule 225 mg

Indications