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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: April 22, 2008
Last updated: August 19, 2014
Last verified: August 2014

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

Condition Intervention Phase
Candidiasis, Oral
Drug: micafungin
Drug: caspofungin
Phase 3

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
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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Comparative incidence of success, defined as complete clearing of esophageal lesions [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall therapeutic response [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]
  • Mycological response [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]
  • Clinical response [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Enrollment: 454
Study Start Date: June 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Daily dose
Drug: micafungin
Other Names:
  • Mycamine
  • FK463
Active Comparator: 2 Drug: caspofungin
Experimental: 3
Every other day dose, alternating with placebo
Drug: micafungin
Other Names:
  • Mycamine
  • FK463


Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00665639

5 Sites
Buenos Aires, Argentina
Cordoba, Argentina
Neuquen, Argentina
Santa Fe, Argentina
Barretos, Brazil
3 Sites
Belo Horizonte, Brazil
Boqueirao-Santos, Brazil
Campinas, Brazil
2 Sites
Curitiba, Brazil
Nova Iguacu, Brazil
Parquelandia-Fortaleza, Brazil
7 Sites
Sao Paulo, Brazil
4 Sites
Lima, Peru
South Africa
Gaborone, Botswana, South Africa
Windoek, Nambia, South Africa
Arcadia-Pretoria, South Africa
Benoni, South Africa
2 Sites
Bloemfontein, South Africa
Cape Town, South Africa
Centurion, South Africa
Dundee, South Africa
Durban, South Africa
Hatfield-Pretoria, South Africa
Olifantsfontein, South Africa
2 Sites
Port Elizabeth, South Africa
Potchefstroom, South Africa
Pretoria, South Africa
Pretoria West, South Africa
Reiger Park, South Africa
Richards Bay, South Africa
Somerset West, South Africa
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use central contact Astellas Pharma US, Inc.
  More Information

Additional Information:
No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc Identifier: NCT00665639     History of Changes
Other Study ID Numbers: 03-7-008
Study First Received: April 22, 2008
Last Updated: August 19, 2014
Health Authority: South Africa: National Health Research Ethics Council
Peru: Ethics Committee
Brazil: National Committee of Ethics in Research
Argentina: Human Research Bioethics Committee

Keywords provided by Astellas Pharma Inc:
Esophageal Candidiasis

Additional relevant MeSH terms:
Candidiasis, Oral
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 09, 2015