A Phase 4 interventional study of duloxetine in Osteoarthritis and Pain, sponsored by University of Washington. Completed. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-02-07.
Sponsored by University of Washington · Phase 4, Interventional, and Treatment
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 the first two weeks. All subjects will then be placed on 60-90mg per day of duloxetine. Primary outcome assessment will compare pain intensity at 2 weeks (after placebo) to that at 12 weeks (after 10 weeks of duloxetine treatment).
Study Hypothesis:
In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 60-90 mg Duloxetine per day over 10 weeks will provide significant additional pain relief over that achieved with placebo(> 30% reduction after Duloxetine treatment).
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 25 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Current suicidal ideation
All subjects receive placebo for the first two weeks and then duloxetine for the next 10 weeks, but they are blind to what they are receiving.
Drug: duloxetine
Weeks 0-2 placebo Weeks 2-3 30mg duloxetine Weeks 3-4 60mg duloxetine Weeks 4-12 60-90mg duloxetine Week 13 30 mg duloxetine Week 14 stop
Difference in average pain intensity on Brief Pain Inventory
Time frame: between 2 weeks and 12 weeks
Difference in pain intensity on Western Ontario McMasters University Osteoarthritis Index (WOMAC)
Time frame: Difference between 2 weeks and 12 weeks
Difference in pain interference on Western Ontario McMasters University Osteoarthritis Index (WOMAC)
Time frame: Difference between 2 and 12 weeks
Difference in role function as assessed by the Sheehan Disability Scales
Time frame: Difference between 2 and 12 weeks
Difference on observed physical function as assessed by the Aggregated Locomotor Function score
Time frame: Difference between 2 and 12 weeks
No study locations are listed for this record.
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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University of Washington