Milnacipran for Chronic Pain in Knee Osteoarthritis

PHASE4CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Knee OsteoarthritisDegenerative Joint DiseaseChronic Pain
Interventions
DRUG

Milnacipran

Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.

DRUG

Placebo

Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Forest Laboratories

INDUSTRY

lead

Dr. Norman Harden

OTHER