Clinical Trial: Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 3, Randomized, Double-Blind, Comparative Trial of Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis
Brief Summary: To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis
Detailed Summary:
Sponsor: Astellas Pharma Inc
Current Primary Outcome: Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy [ Time Frame: End of Therapy ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical response at end of therapy of cleared or improved [ Time Frame: End of Therapy ]
- Mucosal response at end of therapy of cleared or improved [ Time Frame: End of Therapy ]
Original Secondary Outcome: Same as current
Information By: Astellas Pharma Inc
Dates:
Date Received: April 22, 2008
Date Started: August 2003
Date Completion:
Last Updated: September 17, 2014
Last Verified: September 2014
