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| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) |
| Estimated Enrollment: | 1588 |
| Study Start Date: | April 2000 |
| Estimated Study Completion Date: | February 2004 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
40 years and above, both genders, who have clinical and radiographic osteoarthritis symptomatic for at least six months.
Contacts and 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 | |
More Information
| Study ID Numbers: | GAIT |
| Study First Received: | April 5, 2002 |
| Last Updated: | November 1, 2006 |
| ClinicalTrials.gov Identifier: | NCT00032890 |
| Health Authority: | United States: Food and Drug Administration |
|
osteoarthritis knee pain |
|
Celecoxib Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Pain Rheumatic Diseases |
