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NCT00665639 Clinical Trial

Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis

Candidiasis, Oral Clinical Trial

Official title:
A Phase 3, Randomized, Double-Blind, Comparative Trial of Two Dosing Regimens of Micafungin (FK463) Versus Caspofungin for the Treatment of Esophageal Candidiasis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00665639
Other study ID # 03-7-008
Secondary ID
Status Completed
Phase Phase 3
First received April 22, 2008
Last updated August 19, 2014
Start date June 2004
Est. completion date December 2004

Study information
Verified date August 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority South Africa: National Health Research Ethics CouncilPeru: Ethics CommitteeBrazil: National Committee of Ethics in ResearchArgentina: Human Research Bioethics Committee
Study type Interventional

Clinical Trial Summary

To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis

Recruitment information / eligibility
Status Completed
Enrollment 454
Est. completion date December 2004
Est. primary completion date December 2004
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Esophageal candidiasis confirmed by endoscopy

- Negative pregnancy test for female patients of childbearing potential

Exclusion Criteria:

- Pregnant or nursing female patient

- Evidence of liver disease

- 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

- Received an oral or topical antifungal agent within 48 hours or a systemic antifungal agent within 72 hours of first dose of study drug

- Known to be non-responsive to therapy in any prior systemic antifungal clinical trail

- Experienced > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy

- History of anaphylaxis attributed to echinocandin class of antifungals

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• micafungin
IV
• caspofungin
IV

Locations
Country Name City State
Argentina 5 Sites Buenos Aires
Brazil 3 Sites Belo Horizonte
Brazil 2 Sites Curitiba
Brazil 7 Sites Sao Paulo
Peru 4 Sites Lima
South Africa 2 Sites Bloemfontein
South Africa 2 Sites Port Elizabeth

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Argentina,  Brazil,  Peru,  South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparative incidence of success, defined as complete clearing of esophageal lesions End of Therapy No
Secondary Overall therapeutic response End of Therapy No
Secondary Mycological response End of Therapy No
Secondary Clinical response End of Therapy No
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