Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee

PHASE3CompletedINTERVENTIONAL
Enrollment

596

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

October 31, 2010

Study Completion Date

April 30, 2011

Conditions
Osteoarthritis of the Knee
Interventions
DEVICE

1.2% Sodium Hyaluronate

IA-BioHA is supplied in a disposable 7 ml nominal volume glass syringe containing 60 mg/5 ml of 1.2% sodium hyaluronate. Participants are given a single injection in the target knee on Day 1 of the double-blind period and optionally on the first day of the open-label period (approximately week 27).

DEVICE

Buffered Saline

IA-SA is supplied in a disposable 7 ml nominal volume glass syringe containing 5 ml of phosphate buffered saline. Participants are given a single injection in the target knee on Day 1 of the double-blind period.

Trial Locations (34)

Unknown

Apex Clinical Trials, LLC, Homewood

Tucson Orthopaedic Institute, Tucson

St. Joseph's Mercy Clinic, Hot Springs

Rx Medical Research of Arkansas, Inc, Little Rock

Southbay Pharma Research, Buena Park

Providence Clinical Research, Burbank

Triwest Research Associates, La Mesa

UCLA-Division of Rheumatology, Los Angeles

Investigational Site, Santa Barbara

Colorado Arthritis Center, PC, Englewood

Front Range Clinical Research, Wheat Ridge

New England Research Associates, LLC, Trumball

International Physicians Research, Aventura

Investigational Site, Fort Lauderdale

Sunrise Medical Research, Lauderdale Lakes

Tri-County Orthopaedic Center, Leesburg

Clinical Research Center LLC, Wellington

National Pain Research Institute, LLC, Winter Park

Georgia Institute for Clinical Research, Marietta

Pinnacle Orthopaedics and Sports Medicine, Marietta

Lee Research Institute, Shawnee

Professional Research Network of Kansas, Wichita

New Jersey Physicians, LLC, Passaic

Research Department, Bone & Joint Hospital at St. Anthony, Oklahoma City

Omega Medical Research, Warwick

Palmetto Medical Research, Mt. Pleasant

Palmetto Clinical Trial Services, LLC, Simpsonville

Black Hills Orthopedic & Spine Center, Rapid City

Holston Medical Group, Kingsport

McKenzie Medical Center, McKenzie

Texas Orthopedic Specialists, PA, Grapevine

Memorial Bone & Joint Research Foundation, Houston

Discovery Clinical Trials (DCT) - Stone Oak, LLC, San Antonio

Northwest Clinical Research Center, Bellevue

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY