Official Title: “A Phase 3, Randomized, Double-Blind, Comparative Trial of Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis”

To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2004

Intervention(s) in this Clinical Trial

• Drug: Micafungin
  • IV
• Drug: Fluconazole
  • IV

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy
  • Time Frame: End of Therapy
    Safety Issue?: No

Secondary Measures

• Clinical response at end of therapy of cleared or improved
  • Time Frame: End of Therapy
    Safety Issue?: No
• Mucosal response at end of therapy of cleared or improved
  • Time Frame: End of Therapy
    Safety Issue?: No

Inclusion Criteria:

• Diagnosis of esophageal candidiasis confirmed by endoscopy
• Negative pregnancy test in females of childbearing potential

Exclusion Criteria:

• Pregnant or nursing
• Evidence of liver disease
• Presence of another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
• Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
• Receipt of an oral or topical antifungal agent within 48 hours or a systemic agent within 72 hours of first dose of study drug
• Non-responsive to therapy in any prior systemic antifungal clinical trail
• History of > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
• History of anaphylaxis attributed to azole compounds or echinocandin class of antifungals

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use central contact Study Director Astellas Pharma US, Inc.  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666185

Study ID Number: 03-7-005

ClinicalTrials.gov Identifier: NCT00666185

Health Authority: South Africa: National Health Research Ethics Council

Link to results on ClinicalStudyResults.org