At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 16 enrolled

Drug / intervention

Posaconazole +1 moredrug

Likely dose

Posaconazole 400 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00423267

NCT00423267Phase 3Completed

Compare CT.gov

A Multicenter, Randomized, Controlled, Double-Blind, Double-Dummy, Two-Arm Study of Posaconazole vs Fluconazole in the Treatment of Coccidioidomycosis

Merck Sharp & Dohme LLC·interventional·Posted Jan 18, 2007·Updated Apr 11, 2017

In Brief

A Phase 3 clinical trial evaluating Posaconazole and Fluconazole for Coccidioidomycosis. Completed, enrolled 16 participants.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCoccidioidomycosis

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedJan 2007

Enrollment StartMay 2007

Primary CompletionMay 2009

TodayJul 2026

First PostedJan 18, 2007

Enrollment StartMay 1, 2007

Primary CompletionMay 1, 2009

TodayJul 2, 2026

Enrollment to primary: 2 yearsPosted 19.5 years ago

Interventions

Posaconazoledrug

Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months

Fluconazoledrug

Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months