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

Phase 4

Completed

• Conditions: Osteoarthritis; Pain
• Interventions: Drug: Venlafaxine

• Registration Number: NCT00611676
• Lead Sponsor: University of Washington

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2008-01
• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-01-25
• Last Update Submitted: 2008-01-25
• Study First Posted: 2008-02-11
• Last Update Posted: 2008-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age 50 - 80 years
• Physician diagnosis of OA in hip, knee or spine
• Significant activity limitation due to pain for at least one month on the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) and average pain more than 5/10 on Brief Pain Inventory despite adequate treatment with acetaminophen or NSAIDs (This will identify an OA group with significant psychological distress and a desire for treatment).
• Depression status is not restricted, but will be monitored with PRIME-MD interview and the SCL-20. We anticipate depressive symptoms will be common in this population due to the above requirement for activity limitation.

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Exclusion Criteria

• Cannot read and write English
• Significant cognitive impairment
• History of psychosis or mania
• Current suicidal ideation
• Current substance abuse or dependence
• Current use of opioids or any antidepressant medication
• Use of investigational drug within the past month

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Venlafaxine	All subjects receive placebo for the first two weeks and then Venlafaxine for the next 10 weeks, but they are blind to what they are receiving

Primary Outcome Measures

Name	Time	Method
Difference in average pain intensity on Brief Pain Inventory	Between 2 weeks and 12 weeks
Difference in pain intensity on Western Ontario McMasters University Osteoarthritis Index (WOMAC)	Between 2 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Difference in pain interference on Western Ontario McMasters University Osteoarthritis Index (WOMAC)	Between 2 and 12 weeks
Difference in role function as assessed by the Sheehan Disability Scale	Between 2 and 12 weeks
Difference in observed physical function as assessed by the Aggravated Locomotor Function Score	Between 2 and 12 weeks