CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 54 enrolled
Drug / intervention
Montelukast first, then placebo +1 moredrug
Likely dose
Montelukast first, then placebo 4 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/NCT00903357
NCT00903357N/ACompleted
CompareCT.gov

A Double Blind, Randomized, Crossover Study to Compare the Effectiveness of Montelukast on Atopic Dermatitis in Koreans

Pyun BokYang·interventional·Posted May 18, 2009·Updated Dec 14, 2015

In Brief

A clinical study evaluating Montelukast first, then placebo and Placebo first, then Montelukast for Atopic Dermatitis. Completed, enrolled 54 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the clinical effectiveness of Montelukast in children (2\~6 years old) with atopic dermatitis and identify the pathophysiologic background of Montelukast on the role of modulating the atopic dermatitis measured by urinary Leukotriene 4 (LTE4) and Eosinophil protein X(EDN).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesSouth Korea
CollaboratorsMerck Sharp & Dohme LLC

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2009
Enrollment StartAug 1, 2009
Primary CompletionAug 1, 2010
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.1 years ago

Interventions

Montelukast first, then placebodrug

Patients in "Montelukast first, then placebo" will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks. And after 2 weeks wash-out period, they will receive chewable ascorbic acid placebo for 8 weeks. Patients in "Placebo first, then Montelukast" are received chewable ascorbic acid placebo for 8 weeks. And after 2 weeks wash-out period, they will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks.

Placebo first, then Montelukastdrug

Patients in "Montelukast first, then placebo" will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks. And after 2 weeks wash-out period, they will receive chewable ascorbic acid placebo for 8 weeks. Patients in "Placebo first, then Montelukast" are received chewable ascorbic acid placebo for 8 weeks. And after 2 weeks wash-out period, they will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks.