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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00666185 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Randomized, Double-Blind, Comparative Trial of Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis |
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 |
---|---|
1: Experimental |
Drug: Micafungin
IV
|
2: Active Comparator |
Drug: Fluconazole
IV
|
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
2 Sites | |
Curitiba, Brazil | |
2 Sites | |
Campinas, Brazil | |
5 Sites | |
Belo Horizonte, Brazil | |
Nova Iguacu, Brazil | |
8 Sites | |
Sao Paulo, Brazil | |
Porto Alegre, Brazil | |
Parquelandia - Fortaleza, Brazil | |
4 Sites | |
Rio de Janeiro, Brazil | |
Boqueirao - Santos, Brazil | |
Maruipe Victoria, Brazil | |
Goiania, Brazil | |
2 Sites | |
Salvador, Brazil | |
Barretos, Brazil | |
Sao Jose do Rio Preto, Brazil | |
Quinta - Natal, Brazil | |
Abadia Uberaba, Brazil | |
Peru | |
4 Sites | |
Lima, Peru | |
South Africa | |
3 Sites | |
Pretoria, South Africa | |
Westdene - Bloemfontein, South Africa | |
Centurion, South Africa | |
Paarl, South Africa | |
Johannesburg, South Africa | |
Arcadia-Pretoria, South Africa | |
Pretoria West, South Africa | |
Cape Town, South Africa | |
Richards Bay, South Africa | |
2 Sites | |
Bloemfontein, South Africa | |
Olifantsfontein, South Africa | |
Bellville - Cape Town, South Africa | |
Dundee, South Africa | |
Potchefstroom, South Africa | |
Reiger Park, South Africa | |
Brits, South Africa | |
Somerset West, South Africa | |
Hatfield - Pretoria, South Africa | |
2 Sites | |
Port Elizabeth, South Africa | |
2 Sites | |
Durban, South Africa |
Study Director: | Use central contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry ) |
Study ID Numbers: | 03-7-005 |
Study First Received: | April 22, 2008 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00666185 History of Changes |
Health Authority: | South Africa: National Health Research Ethics Council; Peru: Ethics Committee; Brazil: National Committee of Ethics in Research |
Micafungin Esophageal Candidiasis Fluconazole |
Mouth Diseases Fluconazole Candidiasis, Oral Candidiasis Clotrimazole Miconazole Tioconazole |
Micafungin Mycoses Esophageal Disorder Antifungal Agents Esophageal Diseases Stomatognathic Diseases |
Fluconazole Mouth Diseases Anti-Infective Agents Mycoses Candidiasis, Oral Candidiasis |
Therapeutic Uses Antifungal Agents Stomatognathic Diseases Pharmacologic Actions Micafungin |