NCT00390780

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

A Comparative Randomized, Double-blind, Double-Dummy, Multicenter Study of the Efficacy and Safety of Miconazole Lauriad 50mg Administered Once a Day and Mycelex Troches (Clotrimazole 10mg) Administered Five Times a Day in the Treatment of Oropharyngeal Candidiasis in Immunocompromised Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 578 (actual)
• Sponsor: Valerio Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	miconazole Lauriad	50 mg buccal tablet once a day for 14 days
DRUG	Clotrimazole	10mg troches administered Five Times a Day for 14 days

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-12-01
• Completion: 2008-01-01
• First posted: 2006-10-20
• Last updated: 2013-09-16
• Results posted: 2013-08-29

Locations

27 sites across 2 countries: United States, Canada