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Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)

This study has been completed.

Sponsors and Collaborators: Department of Veterans Affairs
National Center for Complementary and Alternative Medicine (NCCAM)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032890
  Purpose

This study will determine whether glucosamine, chondroitin sulfate and/or the combination of glucosamine and chondroitin sulfate are more effective than placebo and whether the combination is more effective than glucosamine or chondroitin sulfate alone in the treatment of knee pain associated with osteoarthritis (OA) of the knee after six months of follow-up. These substances, marketed in the United States as dietary supplements, have been widely touted by the lay press and by anecdotal personal experience as effective in treating OA. To date, however, only a few small studies have been published in the worldwide literature. The study proposed herein has been carefully constructed to definitively determine the efficacy of these agents.


Condition Intervention Phase
Osteoarthritis
Drug: glucosamine
Drug: chondroitin sulfate
Drug: glucosamine and chondroitin sulfate combined
Drug: celecoxib
Phase III

MedlinePlus related topics:   Osteoarthritis   

ChemIDplus related topics:   Celecoxib    4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide    Chondroitin    Chondroitin sulfates    Translagen    Glucosamine sulfate    Glucosamine    Glucosamine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:   1588
Study Start Date:   April 2000
Estimated Study Completion Date:   February 2004

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

40 years and above, both genders, who have clinical and radiographic osteoarthritis symptomatic for at least six months.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032890

Locations
United States, Alabama
University of Alabama at Birmingham    
      Birmingham, Alabama, United States, 35294-7201
United States, Arizona
*University of Arizona Arthritis Center    
      Tucson, Arizona, United States, 85724
United States, California
*Cedars-Sinai Medical Center    
      Los Angeles, California, United States, 90048
*University of California San Francisco    
      San Francisco, California, United States, 94110
*University of California, Los Angeles    
      Los Angeles, California, United States, 90095
United States, Illinois
Northwestern University    
      Chicago, Illinois, United States, 60611
United States, Indiana
*Indiana University School of Medicine    
      Indianapolis, Indiana, United States, 46202-5103
United States, Kansas
*Arthritis Research and Clinical Centers    
      Wichita, Kansas, United States, 67214
United States, Nebraska
University of Nebraska Medical Center    
      Omaha, Nebraska, United States, 68198-3025
United States, New York
Hospital for Joint Diseases    
      New York, New York, United States, 10003
United States, Ohio
*Case Western Reserve University    
      Beachwood, Ohio, United States, 44122
United States, Pennsylvania
University of Pennsylvania    
      Philadelphia, Pennsylvania, United States, 19104
*University of Pittsburgh    
      Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Arthritis Consultation Center    
      Dallas, Texas, United States, 75231-4496
United States, Utah
*University of Utah    
      Salt Lake City, Utah, United States, 84132
United States, Washington
Virginia Mason Research Center    
      Seattle, Washington, United States, 98101

Sponsors and Collaborators
  More Information

Publications of Results:

Study ID Numbers:   GAIT
First Received:   April 5, 2002
Last Updated:   November 1, 2006
ClinicalTrials.gov Identifier:   NCT00032890
Health Authority:   United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
osteoarthritis  
knee pain  

Study placed in the following topic categories:
Celecoxib
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Pain
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 25, 2008




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