drugset / Trial / NCT03100318
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Benzbromarone | Small molecule | 50 mg | Oral |
| Subject | Dotinurad | Small molecule | 2 mg | Oral |