CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 578 enrolled
Drug / intervention
miconazole Lauriad +1 moredrug
Likely dose
miconazole Lauriad 50 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/NCT00390780
NCT00390780Phase 3Completed

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

Valerio Therapeutics·interventional·Posted Oct 20, 2006·Updated Sep 16, 2013

In Brief

A Phase 3 clinical trial evaluating miconazole Lauriad and Clotrimazole for HIV Infections. Completed, enrolled 578 participants across 27 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 20, 2006
Enrollment StartJul 1, 2006
Primary CompletionDec 1, 2007
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.7 years ago

Interventions

miconazole Lauriaddrug

50 mg buccal tablet once a day for 14 days

Clotrimazoledrug

10mg troches administered Five Times a Day for 14 days