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Micafungin vs. Fluconazole for Esophageal Candidiasis
NCT00666185Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2003
- Primary completion
- Feb 2004
- Countries
- 3
- Sponsor
- Astellas Pharma
- Modality
- Small Molecules
- Drugs
- micafungin
- Conditions
- esophageal candidiasis
01
Overview
Phase 3, randomised, double-blind trial of micafungin in esophageal candidiasis (2 arms), sponsored by Astellas Pharma. Primary endpoint: Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy. Started Aug 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Micafungin Arm
Experimental Arm receiving intravenous Micafungin.
Fluconazole Arm
Active Comparator Arm receiving intravenous Fluconazole.
03
Endpoints
Primary
Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy
Secondary
Clinical response at end of therapy of cleared or improved
Mucosal response at end of therapy of cleared or improved
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