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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00665639
First received: April 22, 2008
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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
IV
Other Names:
  • Mycamine
  • FK463
Active Comparator: 2 Drug: caspofungin
IV
Experimental: 3
Every other day dose, alternating with placebo
Drug: micafungin
IV
Other Names:
  • Mycamine
  • FK463

  Eligibility

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

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
  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: NCT00665639

Locations
Argentina
5 Sites
Buenos Aires, Argentina
Cordoba, Argentina
Neuquen, Argentina
Santa Fe, Argentina
Brazil
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
Peru
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
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov 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:
Micafungin
Esophageal Candidiasis
caspofungin

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Oral
Mouth Diseases
Mycoses
Stomatognathic Diseases
Caspofungin
Micafungin
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014