NCT00423371

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

A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of EUFLEXXA™ for Treatment of Osteoarthritis (OA) of the First Carpometacarpal (CMC) Joint

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, double-blind, randomized, parallel-group, active-controlled trial will be performed in approximately 80 subjects with chronic idiopathic osteoarthritis (OA) of the first carpo-metacarpal joint (CMC).

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2007-01-18
• Last updated: 2011-05-19

Locations

1 site across 1 country: United States