Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)

N/ACompletedNCT00943683

Organon and Co256 enrolled

Overview

A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

256

Conditions

Asthma

Interventions

montelukast sodiumDRUG

Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks

Comparator: PlaceboDRUG

Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 24 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is in good, stable health * Patient has been fed solid foods for at least 1 month * Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit * Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines Exclusion Criteria: * Patient was hospitalized at the start of the study or required a visit to the emergency room due to asthma with in past 2 weeks

Outcomes

Primary Outcomes

Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

Time frame: During the 6 weeks of treatment

Data from ClinicalTrials.gov

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