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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:


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
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

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: 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