COMPARATIVE STUDY OF PHASE 3, RANDOMIZED, DOUBLE BLIND MICAFUNGIN (FK463) VERSUS FLUCONAZOL FOR THE TREATMENT OF CANDIDIASIS ESOFAGITIS

Phase 1

• Conditions: -B378 Candidiasis of other sites; Candidiasis of other sites; B378

• Registration Number: PER-036-03
• Lead Sponsor: FUJISAWA HEALTH CARE INC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-07-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Endoscopic cure<br>Measure:Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy<br>Timepoints:End of Therapy<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical analysis<br><br>Measure:Clinical response at end of therapy of cleared or improved<br>Timepoints:End of Therapy<br>