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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00423267 |
To evaluate the efficacy of posaconazole (POS) in the treatment of coccidioidomycosis by comparing POS to fluconazole (FLU) after 6 months of treatment based on a standardized scoring system ("Mycoses Study Group [MSG] Coccidioidomycosis Scoring System").
Condition | Intervention | Phase |
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Coccidioidomycosis |
Drug: Posaconazole Drug: Fluconazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Controlled, Double-Blind, Double-Dummy, Two-Arm Study of Posaconazole vs Fluconazole in the Treatment of Coccidioidomycosis |
Estimated Enrollment: | 250 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
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Drug: Posaconazole
Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months
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2: Active Comparator
Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months
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Drug: Fluconazole
Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months
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Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Key Exclusion Criteria Excluded Medications at Enrollment
Excluded Concomitant Conditions
Excluded Baseline Laboratory Studies
General Exclusion Criteria
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04558 |
Study First Received: | January 17, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00423267 |
Health Authority: | United States: Food and Drug Administration |
Fluconazole Mycoses Clotrimazole Miconazole |
Coccidioidomycosis Tioconazole Influenza, Human Posaconazole |
Trypanocidal Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents |
Therapeutic Uses Antifungal Agents Antibiotics, Antifungal Pharmacologic Actions |