Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00666185
First received: April 22, 2008
Last updated: June 26, 2008
Last verified: June 2008
  Purpose

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


Condition Intervention Phase
Candidiasis, Oral
Drug: Micafungin
Drug: Fluconazole
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 Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response at end of therapy of cleared or improved [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]
  • Mucosal response at end of therapy of cleared or improved [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Enrollment: 523
Study Start Date: August 2003
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Micafungin
IV
Other Names:
  • Mycamine
  • FK463
Active Comparator: 2 Drug: Fluconazole
IV
Other Name: Diflucan

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666185

Locations
Brazil
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
Peru
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
3 Sites
Pretoria, South Africa
Pretoria West, South Africa
Reiger Park, South Africa
Richards Bay, South Africa
Somerset West, South Africa
Westdene - Bloemfontein, South Africa
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use central contact Astellas Pharma US, Inc.
  More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier: NCT00666185     History of Changes
Other Study ID Numbers: 03-7-005
Study First Received: April 22, 2008
Last Updated: June 26, 2008
Health Authority: South Africa: National Health Research Ethics Council
Peru: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by Astellas Pharma Inc:
Micafungin
Esophageal Candidiasis
Fluconazole

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Oral
Mycoses
Mouth Diseases
Stomatognathic Diseases
Fluconazole
Micafungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014