Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

Verified by: Astellas Pharma Inc, June 2008
First Received: April 22, 2008 | Last Updated: June 26, 2008 | Phase: Phase 3 | Start Date: August 2003
Overall Status: Completed | Estimated Enrollment: 523
  • …
  • Tell a FriendPrint

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

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Astellas Pharma Inc Industry

Overall Clinical Trial Officials and Contacts

Use central contact Study Director Astellas Pharma US, Inc.  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00666185