Trial intelligence / Profile preview

Montelukast in Children With Atopic Dermatitis Induced by Food Allergens

NCT00557284Phase 4

Key facts

Status: Completed
Start: Mar 2008
Primary completion: May 2009
Countries: 1
Modality: Small Molecules

Drugs: montelukast
Conditions: atopic dermatitis (AD)

Overview

Phase 4, randomised, double-blind trial in atopic dermatitis (AD) comparing Montelukast with Placebo (2 arms). Primary endpoints: Change in Percentage of Body Involvement at 9 weeks, Mean Change in Investigator Global Assessment at 9 weeks and 3 more. Started Mar 2008; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Montelukast
Montelukast 4 mg or 5 mg (based on age) oral granules or chewable tablet, PO QD
Placebo
Placebo oral granules or chewable tablet, PO QD

Who it enrols

Children aged 1-8 years with mild to moderate atopic dermatitis (>=5% BSA) associated with food allergens, positive skin/RAST test, and GI symptoms. Excludes severe asthma, primary immune deficiency, and underlying renal/liver disease.

Endpoints

Primary

Change in Percentage of Body Involvement9 weeks
Mean Change in Investigator Global Assessment9 weeks
Mean Change in Caregivers Perception of Disease Control9 weeks
Mean Change in Pruritus9 weeks
Mean Change in Weekly Use of Rescue Medication for AD Flare-up9 weeks

Secondary

Mean Change in Serum and Urinary Inflammatory Marker Levels9 weeks
Mean Change in Serum IgE Levels9 weeks
Mean Change in Gastrointestinal Symptom Rating Scale9 weeks

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