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Comparative Trial of Micafungin Versus Fluconazole for Treating 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: NCT00666185
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis

Condition or disease Intervention/treatment Phase
Candidiasis, Oral Drug: Micafungin Drug: Fluconazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 523 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 Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis
Study Start Date : August 2003
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: 1 Drug: Micafungin
Other Names:
  • Mycamine
  • FK463

Active Comparator: 2 Drug: Fluconazole
Other Name: Diflucan

Primary Outcome Measures :
  1. Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy [ Time Frame: End of Therapy ]

Secondary Outcome Measures :
  1. Clinical response at end of therapy of cleared or improved [ Time Frame: End of Therapy ]
  2. Mucosal response at end of therapy of cleared or improved [ 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:

  • 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

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): NCT00666185

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Abadia Uberaba, Brazil
Barretos, Brazil
5 Sites
Belo Horizonte, Brazil
Boqueirao - Santos, Brazil
2 Sites
Campinas, Brazil
2 Sites
Curitiba, Brazil
Goiania, Brazil
Maruipe Victoria, Brazil
Nova Iguacu, Brazil
Parquelandia - Fortaleza, Brazil
Porto Alegre, Brazil
Quinta - Natal, Brazil
4 Sites
Rio de Janeiro, Brazil
2 Sites
Salvador, Brazil
Sao Jose do Rio Preto, Brazil
8 Sites
Sao Paulo, Brazil
4 Sites
Lima, Peru
South Africa
Arcadia-Pretoria, South Africa
Bellville - Cape Town, South Africa
2 Sites
Bloemfontein, South Africa
Brits, South Africa
Cape Town, South Africa
Centurion, South Africa
Dundee, South Africa
2 Sites
Durban, South Africa
Hatfield - Pretoria, South Africa
Johannesburg, South Africa
Olifantsfontein, South Africa
Paarl, South Africa
2 Sites
Port Elizabeth, South Africa
Potchefstroom, South Africa
Pretoria West, South Africa
3 Sites
Pretoria, South Africa
Reiger Park, South Africa
Richards Bay, South Africa
Somerset West, South Africa
Westdene - Bloemfontein, 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: NCT00666185     History of Changes
Other Study ID Numbers: 03-7-005
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 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
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors