Duloxetine Versus Placebo for Osteoarthritis Knee Pain

Lilly

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis Knee Pain

Treatments: Drug: placebo; Drug: Duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00408421

F1J-MC-HMEP

10546 (Registry Identifier)

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: 231 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female outpatients with osteoarthritis knee pain.

Exclusion criteria

• 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.
• Acute liver injury (such as hepatitis) or severe cirrhosis.
• Previous exposure to duloxetine.
• Body Mass Index (BMI) over 40.
• Major depressive disorder.
• Daily use of narcotics.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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231 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

duloxetine 30 mg, daily (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 6 weeks then duloxetine 60 mg or 120 mg QD, PO for 6 weeks

Treatment:

Drug: Duloxetine

B

Placebo Comparator group

Description:

placebo daily (QD), by mouth (PO) for 13 weeks

Treatment:

Drug: placebo