Clinical Trial: Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3, Randomized, Double-Blind, Comparative Trial of Two Dosing Regimens of Micafungin (FK463) Versus Caspofungin for the Treatment of Esophageal Candidiasis

Brief Summary: To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis

Detailed Summary:
Sponsor: Astellas Pharma Inc

Current Primary Outcome: Comparative incidence of success, defined as complete clearing of esophageal lesions [ Time Frame: End of Therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall therapeutic response [ Time Frame: End of Therapy ]
  • Mycological response [ Time Frame: End of Therapy ]
  • Clinical response [ Time Frame: End of Therapy ]


Original Secondary Outcome: Same as current

Information By: Astellas Pharma Inc

Dates:
Date Received: April 22, 2008
Date Started: June 2004
Date Completion:
Last Updated: August 19, 2014
Last Verified: August 2014