A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
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).
Clinical Details
Official title: A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Difference in average pain intensity on Brief Pain InventoryDifference 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
Eligibility
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
Locations and Contacts
Additional Information
Starting date: September 2004
Last updated: January 25, 2008
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