Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients

Summary

The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).

Timeline

Start

2006-07

Primary completion

2007-12

Completion

2008-01

Outcome

Missed primary endpoint

registry analysis (non-inferiority or equivalence test); Miconazole Lauriad Buccal Tablet vs Clotrimazole Troches; p >0.025 NCT00390780 ↗

Drugs

Indications