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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00686543 |
The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal function and at high risk for Invasive Fungal Infection.
Condition | Intervention | Phase |
---|---|---|
Fungal Infection Acute Myelogenous Leukemia Neutropenia |
Drug: Posaconazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Phase 4 Study of the Pharmacokinetics of Oral Posaconazole (SCH 56592) Among Patients With Compromised Gastrointestinal Function and at High Risk for Invasive Fungal Infection |
Estimated Enrollment: | 75 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group 1: Experimental
POS 200 mg TID with food or oral nutritional supplements for Days 9 to 15.
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Drug: Posaconazole
Posaconazole will be used for prophylaxis
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Group 2: Experimental
POS 400 mg BID with food or oral nutritional supplements for Days 9 to 15.
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Drug: Posaconazole
Posaconazole will be used for prophylaxis
|
Group 3: Experimental
POS 400 mg TID with food or oral nutritional supplements for Days 9 to 15.
|
Drug: Posaconazole
Posaconazole will be used for prophylaxis
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
United States, Georgia | |
Investigational Site 7 | Recruiting |
Atlanta, Georgia, United States, 30322 | |
United States, Michigan | |
Investigational Site 5 | Recruiting |
Detroit, Michigan, United States, 48201 | |
United States, Minnesota | |
Investigational Site 10 | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Investigational Site 6 | Recruiting |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Investigational Site 8 | Recruiting |
Durham, North Carolina, United States, 27710 | |
Belgium | |
Investigational Site 1 | Recruiting |
Leuven, Belgium, 3000 | |
Germany | |
Investigational Site 2 | Recruiting |
Koeln, Germany, 50937 | |
Investigational Site 3 | Recruiting |
Homburg/Saar, Germany, 66424 | |
Investigational Site 4 | Recruiting |
Wuerzburg, Germany, 97080 |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05115, EudraCT No. 2007-003148-31 |
Study First Received: | May 27, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00686543 |
Health Authority: | United States: Food and Drug Administration |
Antifungal Agents Anti-Infective Agents |
Hematologic Diseases Clotrimazole Miconazole Tioconazole Agranulocytosis Acute myelogenous leukemia Leukocyte Disorders Leukemia, Myeloid |
Leukemia, Myeloid, Acute Granulocytopenia Mycoses Leukemia Neutropenia Posaconazole Leukopenia Acute myelocytic leukemia |
Trypanocidal Agents Anti-Infective Agents Communicable Diseases Antiparasitic Agents Antiprotozoal Agents Neoplasms |
Neoplasms by Histologic Type Therapeutic Uses Antifungal Agents Antibiotics, Antifungal Infection Pharmacologic Actions |