drugset / Trial / NCT01144286
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
RandomizedParallel-groupQuadruple-blindTreatment
Summary
In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).
Timeline
- Start
- 2010-06
- Primary completion
- 2011-03
- Completion
- 2011-03
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs Arasertaconazole Nitrate 150 mg vs Arasertaconazole Nitrate 300 mg vs Arasertaconazole 600 mg; p = 0.0630; response rate (%) 80; Regression, Logistic; NCT01144286 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | arasertaconazole | Small molecule | 150 mg | Other |
| Subject | arasertaconazole | Small molecule | 300 mg | Other |
| Subject | arasertaconazole | Small molecule | 600 mg | Other |