Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis - Tabular View

Tracking Information

First Received Date ^ICMJE

April 22, 2008

Last Updated Date

June 26, 2008

Start Date ^ICMJE

August 2003

Primary Completion Date

February 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00666185 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical response at end of therapy of cleared or improved [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]
Mucosal response at end of therapy of cleared or improved [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

Official Title ^ICMJE

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 Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Candidiasis, Oral

Intervention ^ICMJE

Drug: Micafungin
Drug: Fluconazole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

523

Completion Date

February 2004

Primary Completion Date

February 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil, Peru, South Africa

Administrative Information

NCT ID ^ICMJE

NCT00666185

Responsible Party

Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.

Study ID Numbers ^ICMJE

03-7-005

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Use central contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

June 2008

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