CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 55 enrolled
Drug / intervention
ITCZ Oral Solution +1 moredrug
Likely dose
ITCZ Oral Solution 10 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/NCT00784368
NCT00784368Phase 3Completed
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A Pharmacokinetic Study of JK1211 in Patients With Systemic Fungal Infection (SFI) and Patients With Febrile Neutropenia (FN) Suspected of Fungal Infection.

Janssen Pharmaceutical K.K.·interventional·Posted Nov 3, 2008·Updated Jul 25, 2013

In Brief

A Phase 3 clinical trial evaluating ITCZ Oral Solution and ITCZ-IV for Mycoses and 6 related conditions. Completed, enrolled 55 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of itraconazole (ITCZ) oral solution in participants with Systemic Fungal Infection (SFI) and those with febrile (with fever) neutropenia (FN, decrease in white blood cells) suspected of fungal infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMycoses, Candidiasis, Aspergillosis, Cryptococcosis, Blastomycosis, Histoplasmosis, Neutropenia
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 3, 2008
Enrollment StartJan 1, 2008
Primary CompletionApr 1, 2009
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.7 years ago

Interventions

ITCZ Oral Solutiondrug

ITCZ syrup product containing ITCZ 10 mg per ml in dose range of 20 ml to 40 ml daily for 7 days up to 12 weeks

ITCZ-IVdrug

200 mg IV twice daily for 2 days and once daily for the next 1 to 12 days