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Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) Clinical research trials and Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT). Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) clinical trial. Participants oftentimes recieve the finest healthcare available for their Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)  Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)
Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)
For Condition: Osteoarthritis
Status: No longer recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program,National Center for Complementary and Alternative Medicine (NCCAM)
Synopsis: 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. These substances, marketed in the United States as nutritional 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.
Details: 1. Primary Hypotheses The primary analysis will be based on all patients with baseline and follow-up data, including those who withdraw from treatment. While it is not an intent to treat analysis, since patients with inadequate studies and certain other reasons will not be included, inclusion of all patients with baseline and follow-up data will reduce the degree to which differential effectiveness biases the treatment comparisons. A second analysis will be based on all patients who remain on treatment. Following the method by which the sample size target was derived, the analysis to address the primary hypotheses will involve 4 comparisons of change in joint space width from baseline to two-years as measured on the PAC computer using the t-test for independent samples at alpha=.0125: 1) glucosamine vs. placebo, 2) chondroitin vs. placebo, 3) glucosamine + chondroitin vs. placebo and 4) celecoxib vs. placebo. If the two analytic strategies reach different conclusions, we will examine differences between patients who remain on treatment and those who withdraw from treatment early with regard to changes in joint space. 2. Secondary Hypotheses To determine whether the change in JSW for the combination of glucosamine + chondroitin differs from the change in JSW for glucosamine alone or chondroitin alone, 2 t-tests for independent samples will be done. In addition, a two-way analysis of variance with interaction will be done to determine whether the effect of the combination differs from the additive effects of glucosamine and chondroitin alone. This analysis will include four of the five treatment arms (celecoxib excluded). Initially, the analysis will test whether the interaction term is significant (p=.05). If the interaction term is not significant, then the interaction term will be deleted from the model and only main effects will be tested. Because patients will have baseline, one-year and two-year readings, a repeated measures analysis will be done. Since not all patients will have complete data, the mixed-model approach will be used in order to include as many patients in the analysis as possible. The dropout pattern will be tested to determine if there is informative censoring. If so, then additional terms will be added to the model to identify those with less than complete data in order to account for differences in response profiles between those with complete data and those without. The covariance structure will be examined to determine whether an unstructured covariance matrix or a patterned matrix is the most appropriate fit to the data. Fixed-effect terms will include treatment, time and treatment*time. Intercepts will be treated as a random effect. To determine whether the manual measurement of JSW on plain radiographs is equally reproducible as computer generated measurements of digitalized radiographs the following analysis will be done. At baseline, the correlation between readers will be calculated for each method (manual, digital) and the correlations will be statistically tested for equality. This will also be done at one and two years. To determine whether the two methods are equally sensitive to detecting change in JSW, the change from baseline to two years (averaging the two readers) will be calculated for each patient using measurements for each method. Then the variance of the change for each method will be statistically tested for equality. To evaluate long-term efficacy of the treatments, the two-year treatment response rate (defined as a 20% reduction from baseline in the WOMAC pain score) will be calculated. Paralleling the main study protocol, Fisher's exact test will be used to compare each active treatment arm to placebo. Time to achievement of treatment response will be evaluated using Kaplan-Meier life table estimates and comparison of treatment groups will use the log-rank test. Mixed-model analysis of variance using generalized estimating equations will be used to compare the % of treatment responders over time across treatment groups. Treatment of missing data will follow that discussed previously for the mixed-model analysis of change in JSW. Safety will be evaluated by comparing the percentage of people withdrawing from study medications due to adverse events during the two-year follow-up period using Fisher's exact test. Time to withdrawal due to an adverse event will be evaluated using Kaplan-Meier life table estimates and comparison of treatment groups will use the log-rank test. Main Manuscript:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 40 Years/
Genders: Both
Protocol Entry Criteria: 40 years of age or older and have suffered osteoarthritis for at least six months
Total Enrollment: 1588
Location and Contact Information:
Virginia Mason Research Center
Seattle, Washington, 98101
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Hospital for Joint Diseases
New York City, New York, 10003
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
University of California San Francisco
San Francisco, California, 94110
United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202-5103
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3025
United States
Case Western Reserve University
Beachwood, Ohio, 44122
United States
University of Utah
Salt Lake City, Utah, 84132
United States
Arthritis Research and Clinical Centers
Wichita, Kansas, 67214
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294-7201
United States
Arthritis Consultation Center
Dallas, Texas, 75231-4496
United States
Additional Information:
Study ID Numbers: GAIT;
Study Start Date: April 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032890
Other Osteoarthritis Studies:
1. Doxycycline and OA Progression
2. Patient Education in Rheumatoid Arthritis and Osteoarthritis
3. Osteoarthritis Initiative (OAI): A Knee Health Study
4. Brain Imaging - Acupuncture and Osteoarthritis
5. Efficacy of Acupuncture with Physical Therapy for Knee Osteo-Arthritis
Related Studies:
Other Osteoarthritis Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)
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