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

Condition(s) targeted: Osteoarthritis; Pain

Intervention: Venlafaxine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
Mark D. Sullivan, MD, PhD, Principal Investigator, Affiliation: University of Washington

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).

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

Study design: Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Difference in average pain intensity on Brief Pain Inventory

Difference in pain intensity on Western Ontario McMasters University Osteoarthritis Index (WOMAC)

Secondary outcome:

Difference in pain interference on Western Ontario McMasters University Osteoarthritis Index (WOMAC)

Difference in role function as assessed by the Sheehan Disability Scale

Difference in observed physical function as assessed by the Aggravated Locomotor Function Score

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

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

Starting date: September 2004
Ending date: February 2007
Last updated: January 25, 2008