Hyperuricemia Clinical Trial
Official title:
Febuxostat (Zurig) Efficacy & Safety Trial in Comparison With Allopurinol in Hyperuricemic Subjects With or Without Gout
Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine oxidase that exhibits antihyperuricemic activity by reducing the formation of uric acid. The investigators conducted an interventional, two-arm, randomized, open label pilot study on patients with serum urate level ≥ 6.8 mg/dL. Patients were treated with Febuxostat 40 mg Tablets or Allopurinol 300 mg Tablets once daily dose for 90 days to determine the efficacy and safety of Febuxostat in comparison with Allopurinol in Hyperuricemic Subjects with or without Gout.
Patients with hyperuricemia (with or without Gout) were randomized into two groups. One was
treated with Febuxostat 40 mg Tablets and other with Allopurinol 300 mg Tablets once daily
for 3 months period.
Gender, age, height, weight, creatinine and ALT levels, co-morbidities and other
complications were monitored at screening and as per eligibility criteria 50 patients were
enrolled in the study. Efficacy was determined by monitoring serum uric acid levels during
and at the end of treatment. The safety profile has also been monitored during the treatment
period. Investigator collected and recorded all the data of visits in CRF which was analyzed
through SPSS version 20.
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