CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 132 enrolled
Drug / intervention
Itraconazoledrug
Likely dose
Itraconazole 100 milligramfrom 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/NCT00871728
NCT00871728Phase 4Completed
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Change in SCIO (Scoring Clinical Index For Onychomycosis) in Toenail Onychomycosis Treating With Itraconazole Capsules

Janssen Korea, Ltd., Korea·interventional·Posted Mar 30, 2009·Updated Jul 2, 2013

In Brief

A Phase 4 clinical trial evaluating Itraconazole for Onychomycosis, Toe. Completed, enrolled 132 participants.

Detailed Summary

The purpose of this study is to evaluate the participants with toenail onychomycosis (fungal infection of the nail) confirmed positive by potassium hydroxide (KOH) and bacterial identification test after administration of itraconazole (ICZ) capsule, to identify the change in Scoring Clinical Index for Onychomycosis (SCIO) score and to determine the relationship between the change of SCIO score and mycological cure rate and clinical improvement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOnychomycosis, Toe
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 30, 2009
Enrollment StartJan 1, 2007
Primary CompletionMay 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.3 years ago

Interventions

Itraconazoledrug

Itraconazole (ICZ) capsule will be administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle will consist of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment will be 49 weeks.