Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00666185
First received: April 22, 2008
Last updated: September 17, 2014
Last verified: September 2014
  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
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, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00666185     History of Changes
Other Study ID Numbers: 03-7-005
Study First Received: April 22, 2008
Last Updated: September 17, 2014
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 September 18, 2014