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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Viscosupplements

ClinicalTrials.gov processed this record on October 29, 2014