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

NCT00611676 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2008-02-11

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Venlafaxine

Weeks 0-2: placebo. Weeks 2-3: 75 mg Venlafaxine. Weeks 3-4: 150 mg Venlafaxine. Weeks 4-12: 150-225 mg Venlafaxine.

Sponsors & Collaborators

Principal Investigators

  • Mark D. Sullivan, MD, PhD · University of Washington

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2007-02-28
Completion
2007-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00611676 on ClinicalTrials.gov