Status:
COMPLETED
A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Osteoarthritis
Pain
Eligibility:
All Genders
50-80 years
Phase:
PHASE4
Brief Summary
This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may receive duloxetine or placebo during the course of the trial. All subjects will, in fact, receive placebo for...
Eligibility Criteria
Inclusion
- Age 50-80
- 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 \>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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00609557
Start Date
September 1 2004
End Date
February 1 2007
Last Update
February 7 2008
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