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Clinical Trial Details

Trial ID: L0281
Source ID: NCT02579096
Associated Drug: Allopurinol Capsule, 100-800 Mg By Mouth Once Daily
Title: CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02579096/results
Conditions: Gout|Chronic Kidney Diseases
Interventions: DRUG: allopurinol capsule, 100-800 mg by mouth once daily|DRUG: febuxostat tablet 40-120 mg by mouth once daily|DRUG: Placebo, vehicle control (febuxostat-shaped)|DRUG: Placebo, vehicle control (allopurinol-shaped)
Outcome Measures: Primary: Percentage of Participants Experiencing ≥ 1 Gout Flare During Phase 3, Participants were defined as flaring in Phase 3 if they: -1) met 3 of 4 following participant-reported criteria: * a) warm joint(s) * b) swollen joint(s) * c) pain (\>3) at rest on a scale of 0-10 (10 being the worst pain) * d) self-identified gout flare OR -2) reported use of medications to treat flare, Phase III of the study (weeks 49-72 of study duration) |
Sponsor/Collaborators: Sponsor: VA Office of Research and Development
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 950
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-03-06
Completion Date: 2021-04-15
Results First Posted: 2022-01-11
Last Update Posted: 2024-03-29
Locations: VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda, California, 92357, United States|VA San Diego Healthcare System, San Diego, CA, San Diego, California, 92161, United States|San Francisco VA Medical Center, San Francisco, CA, San Francisco, California, 94121, United States|Miami VA Healthcare System, Miami, FL, Miami, Florida, 33125, United States|Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, 60141-5000, United States|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, 02130, United States|Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis, Minnesota, 55417, United States|Mayo Clinic Rochester MN ? RAIN 1, Rochester, Minnesota, 55905, United States|Kansas City VA Medical Center, Kansas City, MO, Kansas City, Missouri, 64128, United States|Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE, Omaha, Nebraska, 68105-1850, United States|University of Nebraska Medical Center ? RAIN 5, Omaha, Nebraska, 68198-3025, United States|Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY, New York, New York, 10010, United States|Asheville VA Medical Center, Asheville, NC, Asheville, North Carolina, 28805, United States|Sanford Bismarck Medical Center ? RAIN 2, Bismarck, North Dakota, 58506, United States|Cincinnati VA Medical Center, Cincinnati, OH, Cincinnati, Ohio, 45220, United States|VA Portland Health Care System, Portland, OR, Portland, Oregon, 97239, United States|Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, Philadelphia, Pennsylvania, 19104, United States|VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, Pittsburgh, Pennsylvania, 15240, United States|Yankton Medical Clinic ? RAIN 3, Yankton, South Dakota, 57078, United States|VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas, Texas, 75216, United States|VA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City, Utah, 84148, United States|White River Junction VA Medical Center, White River Junction, VT, White River Junction, Vermont, 05009-0001, United States|Salem VA Medical Center, Salem, VA, Salem, Virginia, 24153, United States
URL: https://clinicaltrials.gov/show/NCT02579096

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D430 Febuxostat small molecule DB04854 Details