drugset / Trial / NCT03100318

Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

NCT03100318 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

FYU-981 or Benzbromarone are administrated to hyperuricemia patients with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.

Timeline

Start
2017-04-01
Primary completion
2018-04-25
Completion
2018-08-31

Outcome

Met primary endpoint

paper Dotinurad 2 mg was verified to have a non-inferior serum uric acid lowering effect compared with benzbromarone 50 mg PMID 31980978 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Benzbromarone Small molecule 50 mg Oral
Subject Dotinurad Small molecule 2 mg Oral

Indications