At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 256 enrolled
Drug / intervention
Duloxetine +1 moredrug
Likely dose
Duloxetine 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain
In Brief
A Phase 3 clinical trial evaluating Duloxetine and Placebo for Osteoarthritis Knee Pain. Completed, enrolled 256 participants across 7 sites in 4 countries.
Detailed Summary
The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis Knee Pain
CountriesGreece, Russia, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
First PostedFeb 2007
Primary CompletionMay 2008
TodayJul 2026
First PostedFeb 9, 2007
Enrollment StartFeb 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.4 years ago
Interventions
Duloxetinedrug
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
Placebodrug
placebo every day (QD), by mouth (PO) for 13 weeks