Double-Blind,Randomized,Placebo-Controlled Efficacy & Safety Study of EUFLEXXA™ for Treatment of OA of the First CMC

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

September 30, 2007

Study Completion Date

September 30, 2007

Conditions
Osteoarthritis
Interventions
DEVICE

sodium hyaluronate

EUFLEXXA™ is supplied in a single-dose syringe containing 20 mg/2 ml of 1% sodium hyaluronate. Each subject will receive three single dose injections into the target first CMC joint on study weeks 0, 2 and 4.

DEVICE

placebo

Placebo is supplied in a disposable prefilled glass syringe. Each single-dose syringe will contain 2 mL of phosphate buffered saline. Each subject will receive three single dose injections into the target first CMC joint on study weeks 0, 2 and 4.

Trial Locations (1)

33703

All Florida Orthopedic Association, St. Petersburg

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY