NCT00433290

Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.

Conditions

• Osteoarthritis Knee Pain

Interventions

Type	Name	Description
DRUG	Duloxetine	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
DRUG	Placebo	placebo every day (QD), by mouth (PO) for 13 weeks

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-02-09
• Last updated: 2009-09-02
• Results posted: 2009-08-24

Locations

7 sites across 4 countries: United States, Greece, Russia, Sweden