ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00666185
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

April 22, 2008
April 24, 2008
September 18, 2014
August 2003
February 2004   (Final data collection date for primary outcome measure)
Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy [ Time Frame: End of Therapy ]
Same as current
Complete list of historical versions of study NCT00666185 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Candidiasis, Oral
  • Drug: Micafungin
    IV
    Other Names:
    • Mycamine
    • FK463
  • Drug: Fluconazole
    IV
    Other Name: Diflucan
  • Experimental: 1
    Intervention: Drug: Micafungin
  • Active Comparator: 2
    Intervention: Drug: Fluconazole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
523
Same as current
February 2004
February 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Peru,   South Africa
 
 
NCT00666185
03-7-005
Not Provided
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Use central contact Astellas Pharma US, Inc.
Astellas Pharma Inc
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP