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Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)

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ClinicalTrials.gov Identifier: NCT00032890
Recruitment Status : Completed
First Posted : April 8, 2002
Last Update Posted : January 21, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Drug: glucosamine Drug: chondroitin sulfate Drug: glucosamine and chondroitin sulfate combined Drug: celecoxib Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1588 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)
Study Start Date : April 2000
Estimated Study Completion Date : February 2004


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Los Angeles
Los Angeles, California, United States, 90095
*University of California San Francisco
San Francisco, California, United States, 94110
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
VA Office of Research and Development
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00032890     History of Changes
Obsolete Identifiers: NCT00010790
Other Study ID Numbers: GAIT
First Posted: April 8, 2002    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: November 2006

Keywords provided by VA Office of Research and Development:
osteoarthritis
knee pain

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents