Safety and Effectiveness Study of Hyaluronic Acid for Osteoarthritis of the Knee

This study has been completed.

First Received on March 5, 2008. Last Updated on June 21, 2010 History of Changes

Sponsor:	Anika Therapeutics, Inc.
Information provided by:	Anika Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00653432

Purpose

The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

Condition	Intervention
Osteoarthritis	Device: MONOVISC

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Hyaluronic acid Hyaluronate Sodium

U.S. FDA Resources

Further study details as provided by Anika Therapeutics, Inc.:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	350
Study Start Date:	January 2008
Study Completion Date:	February 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Hyaluronic acid	Device: MONOVISC Intra-articular injection Other Name: Sodium hyaluronate

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653432

Locations

United States, Georgia
Resurgens Orthopedics
Cumming, Georgia, United States, 30041

Sponsors and Collaborators

Anika Therapeutics, Inc.

More Information

No publications provided

Responsible Party:	Inna Radzihovsky / Clinical Affairs Manager, Anika Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00653432 History of Changes
Other Study ID Numbers:	AM-0702
Study First Received:	March 5, 2008
Last Updated:	June 21, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Anika Therapeutics, Inc.:

Treatment
Osteoarthritis

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012