NCT01018680

A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 524 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Duloxetine has been studied in pain due to osteoarthritis (OA) in 2 previous placebo controlled clinical trials. In clinical practice, when nonsteroidal anti-inflammatory drugs (NSAIDs) are ineffective in reducing pain due to OA, clinicians often add a second agent without discontinuing NSAIDs. In this study, we will investigate whether adding duloxetine to NSAIDs provides additional pain relief and functional improvement in patients with knee pain due to OA.

Conditions

• Osteoarthritis Knee Pain

Interventions

Type	Name	Description
DRUG	Duloxetine	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.
DRUG	Placebo	Taken by mouth, once daily for 10 weeks

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-11-25
• Last updated: 2012-10-05
• Results posted: 2012-10-05

Locations

35 sites across 2 countries: United States, Puerto Rico