A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)

Phase 3CompletedNCT00700661

Organon and Co500 enrolled

Overview

A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

500

Conditions

Asthma

Interventions

montelukastDRUG

One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks

placebo (unspecified)DRUG

Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or Female between and including the ages of 2 and 5 years * Patient was treated with steroids for an asthma episode in the last 3 months * Patient was admitted to the hospital or emergency room in the last 3 months * Patient is able to chew a tablet Exclusion Criteria: * Patient has been in a research study in the past 4 weeks * Patient has visited the emergency room for an asthma episode in the past week * Patients has a history of stomach, heart, liver, nerve, kidney or blood disease

Outcomes

Primary Outcomes

asthma episodes in 2 - 5 year old children

Time frame: at 12 months

Secondary Outcomes

the number of treatments and duration of asthma episodes

Time frame: at 12 months

Data from ClinicalTrials.gov

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