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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00811928 |
A randomized, open label parallel controlled, multicenter study to evaluate safety and efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic patients for prevention of invasive fungal infection
Condition | Intervention | Phase |
---|---|---|
Leukopenia |
Drug: Posaconazole Drug: Fluconazole |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open Label Parallel Controlled, Multicenter Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension Vs.Fluconazole (Capsule) in High-Risk Leukopenic Patients for Prevention of Invasive Fungal Infection |
Estimated Enrollment: | 240 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Posaconazole 200 mg TID
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Drug: Posaconazole
40mg/ml, 200mg TID
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B: Active Comparator
Fluconazole 400mg QD
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Drug: Fluconazole
50mg/capsule;150mg/capsule; 400mg QD
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Persistent neutropenia (ANC < 500/mm3 [0.5x109/L])or, probable neutropenia in 3-5 days is anticipated. Neutropenia caused by the following reasons prolongs >=7days.
Exclusion Criteria:
Subjects who have taken the following drugs:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05387 |
Study First Received: | December 18, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00811928 |
Health Authority: | China: State Food and Drug Administration |
high-risk leukopenic patients |
Fluconazole Mycoses Clotrimazole Hematologic Diseases Miconazole |
Tioconazole Leukocyte Disorders Posaconazole Leukopenia |
Trypanocidal Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents |
Therapeutic Uses Antifungal Agents Antibiotics, Antifungal Pharmacologic Actions |