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Sponsored by: |
Savient Pharmaceuticals |
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Information provided by: | Savient Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00080210 |
This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study.
Condition | Intervention | Phase |
---|---|---|
Gout |
Drug: Puricase |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects With Hyperuricemia and Refractory Gout |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects to be included in the study are:
Exclusion Criteria:
Subjects to be excluded are those for whom any of the following apply:
United States, Alabama | |
Spain Rehabilitation Center | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
University of California, San Diego | |
La Jolla, California, United States, 92037 | |
United States, Illinois | |
University of Chicago Dept of Medicine | |
Chicago, Illinois, United States, 60637 | |
United States, Kentucky | |
Graves Gilbert Clinic | |
Bowling Green, Kentucky, United States, 42101 | |
United States, Maryland | |
Center for Rheumatology and Bone Research | |
Wheaton, Maryland, United States, 20902 | |
United States, New York | |
North Shore University Hospital Division of Rheumatology | |
Manhasset, New York, United States, 11030 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Oregon | |
Oregon Health & Science University Arthritis & Rheumatic Diseases | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Pride Clinical research Associates | |
Pittsburgh, Pennsylvania, United States, 15219 |
Study ID Numbers: | C0403 |
Study First Received: | March 24, 2004 |
Last Updated: | May 1, 2006 |
ClinicalTrials.gov Identifier: | NCT00080210 |
Health Authority: | United States: Food and Drug Administration |
elevated uric acid Elevated serum uric acid level Symptomatic gout |
Metabolism, Inborn Errors Uric Acid Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases |
Arthritis Hyperuricemia Rheumatic Diseases Metabolic disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout |