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

This study is ongoing, but not recruiting participants.

First Received: March 5, 2008 Last Updated: January 22, 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:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Hyaluronic acid Hyaluronate Sodium

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

Primary Outcome Measures:

Secondary Outcome Measures:

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

Arms	Assigned Interventions
A: Experimental Hyaluronic acid	Device: MONOVISC Intra-articular injection

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:	Anika Therapeutics, Inc. ( Inna Radzihovsky / Clinical Affairs Manager )
Study ID Numbers:	AM-0702
Study First Received:	March 5, 2008
Last Updated:	January 22, 2010
ClinicalTrials.gov Identifier:	NCT00653432 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Anika Therapeutics, Inc.:

Treatment
Osteoarthritis

Additional relevant MeSH terms:

Osteoarthritis, Knee
Immunologic Factors
Musculoskeletal Diseases
Hyaluronic Acid
Osteoarthritis
Joint Diseases

Arthritis
Physiological Effects of Drugs
Adjuvants, Immunologic
Rheumatic Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010