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

This study has been completed.
Sponsor:
Information provided by:
Anika Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00653432
First received: March 5, 2008
Last updated: June 21, 2010
Last verified: June 2010
History of Changes
  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
U.S. FDA Resources

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

Primary Outcome Measures:
  • WOMAC Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Assessment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic osteoarthritis of the knee

Exclusion Criteria:

  • Disorders which could interfere with assessments
  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 May 23, 2013