Trials / Completed
CompletedNCT00423267
POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)
A Multicenter, Randomized, Controlled, Double-Blind, Double-Dummy, Two-Arm Study of Posaconazole vs Fluconazole in the Treatment of Coccidioidomycosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety of posaconazole (POS) in the treatment of coccidioidomycosis. Period A consisted of 2 blinded arms, posaconazole and fluconazole. Recruitment was stopped, and participants in Period A may have been eligible to roll over to an open-label, non-comparitive Period B. During Period B, participants received posaconazole for a treatment duration not to exceed 12 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Posaconazole | Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months |
| DRUG | Fluconazole | Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2009-05-01
- Completion
- 2009-05-01
- First posted
- 2007-01-18
- Last updated
- 2017-04-11
- Results posted
- 2010-06-30
Source: ClinicalTrials.gov record NCT00423267. Inclusion in this directory is not an endorsement.