Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Schering-Plough |
---|---|
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
|
Drug: Posaconazole
40mg/ml, 200mg TID
|
B: Active Comparator
Fluconazole 400mg QD
|
Drug: Fluconazole
50mg/capsule;150mg/capsule; 400mg QD
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Neutropenia caused by the following reasons prolongs >=7days.
MDS shifts to AML and bone marrow arrest induction chemotherapy is required ( not including acute phase of CML)
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: | August 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00811928 History of Changes |
Health Authority: | China: State Food and Drug Administration |
high-risk leukopenic patients |
Fluconazole Anti-Bacterial Agents Anti-Infective Agents Mycoses Hematologic Diseases |
Antifungal Agents Leukocyte Disorders Posaconazole Leukopenia |
Fluconazole Anti-Infective Agents Trypanocidal Agents Antiprotozoal Agents Hematologic Diseases Leukocyte Disorders Pharmacologic Actions |
Mycoses Antiparasitic Agents Antifungal Agents Therapeutic Uses Antibiotics, Antifungal Leukopenia Posaconazole |