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Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of 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. Identifier: NCT00665639
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : August 20, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Candidiasis, Oral Drug: micafungin Drug: caspofungin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 454 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Comparative incidence of success, defined as complete clearing of esophageal lesions [ Time Frame: End of Therapy ]

Secondary Outcome Measures :
  1. Overall therapeutic response [ Time Frame: End of Therapy ]
  2. Mycological response [ Time Frame: End of Therapy ]
  3. Clinical response [ Time Frame: End of Therapy ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00665639

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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 West, South Africa
Pretoria, South Africa
Reiger Park, South Africa
Richards Bay, South Africa
Somerset West, South Africa
Sponsors and Collaborators
Astellas Pharma Inc
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Study Director: Use central contact Astellas Pharma US, Inc.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Astellas Pharma Inc Identifier: NCT00665639     History of Changes
Other Study ID Numbers: 03-7-008
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by Astellas Pharma Inc:
Esophageal Candidiasis
Additional relevant MeSH terms:
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Candidiasis, Oral
Mouth Diseases
Stomatognathic Diseases
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action