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Sponsored by: |
SK Chemicals Co.,Ltd. |
---|---|
Information provided by: | SK Chemicals Co.,Ltd. |
ClinicalTrials.gov Identifier: | NCT00821392 |
This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea
Condition | Intervention | Phase |
---|---|---|
Gout |
Drug: Febuxostat |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multi-Center, Double Blinded, Allopurinol-Controlled, Placebo-Controlled Parallel Group, 5-Arm, Dose-Response,Bridging Study to Assess the Efficacy and Safety of Febuxostat in Subject With Gout |
Enrollment: | 181 |
Study Start Date: | August 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 Febuxostat 40mg: Active Comparator | Drug: Febuxostat |
2 Febuxostat 80mg: Active Comparator | Drug: Febuxostat |
3 Febuxostat 120mg: Active Comparator | Drug: Febuxostat |
4 Allopurinol 300mg: Sham Comparator | Drug: Febuxostat |
5 Placebo: Placebo Comparator | Drug: Febuxostat |
This is a multi-center, randomized, double-blind, allopurinol and placebo controlled, parallel, 5 arms, dose response, bridging study of 4 weeks duration.
If subjects pass the screening evaluation after submitting a signed informed consent, they will be randomly assigned to one of the five treatment regimens; febuxostat 40mg, 80mg, 120mg, placebo or allopurinol 300mg. Colchicine 0.6mg QDis given to minimize the risk of gout flares during the washout/run-in period and during the double study period.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
<Day -14>
1.serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no exclusion criteria
Exclusion Criteria:
Responsible Party: | SK Chemicals Co.,Ltd. ( SK Chemicals Co.,Ltd. ) |
Study ID Numbers: | TMX-67 |
Study First Received: | January 12, 2009 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00821392 |
Health Authority: | Korea: Food and Drug Administration |
Metabolism, Inborn Errors Allopurinol Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases |
Arthritis Febuxostat Rheumatic Diseases Metabolic disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout |
Therapeutic Uses Antirheumatic Agents Gout Suppressants Pharmacologic Actions |