Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

Lilly

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis Knee Pain

Treatments: Drug: Duloxetine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00433290

11198 (Registry Identifier)

F1J-MC-HMFG

Details and patient eligibility

About

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

Enrollment: 256 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female outpatients with osteoarthritis knee pain.

Exclusion criteria

• Serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
• Previous exposure to duloxetine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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256 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Duloxetine

B

Placebo Comparator group

Treatment:

Drug: Placebo