At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 524 enrolled
Drug / intervention
Duloxetine +1 moredrug
Likely dose
Duloxetine 30 milligramsfrom 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.
A Randomized, Placebo-Controlled Trial of Duloxetine Added to Nonsteroidal Anti-inflammatory Drugs in Patients With Knee Pain Due to Osteoarthritis Who Have Had Suboptimal Response to Nonsteroidal Anti-inflammatory Drug Treatment.
In Brief
A Phase 3 clinical trial evaluating Duloxetine and Placebo for Osteoarthritis Knee Pain. Completed, enrolled 524 participants across 35 sites in 2 countries.
Detailed Summary
The study will test the hypothesis that, in patients with knee pain due to osteoarthritis (OA) who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) but still have significant knee pain, duloxetine 60 to 120 milligrams (mg) daily for 10 weeks will provide additional reduction in pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis Knee Pain
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
First PostedNov 2009
Primary CompletionApr 2011
TodayJul 2026
First PostedNov 25, 2009
Enrollment StartNov 1, 2009
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.6 years ago
Interventions
Duloxetinedrug
30 milligrams (mg) taken by mouth, once daily for 1 week, followed by 60 to 120 mg taken by mouth, once daily for 9 weeks.
Placebodrug
Taken by mouth, once daily for 10 weeks