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Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)

NCT00092092 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-08-14

No results posted yet for this study

Summary

The purpose of this study is to determine the effect of montelukast, an approved medication, on the lower leg growth rate in children with mild asthma. The primary hypothesis is that the lower leg length (LLL) growth rate for children treated with montelukast compared to placebo will be established.

Conditions

  • Asthma, Bronchial

Interventions

DRUG

Montelukast chewable tablets

Montelukast sodium 5 mg chewable tablets

DRUG

Budesonide inhaler

Budesonide 200 mcg inhalation powder

DRUG

Placebo to montelukast chewable tablets

Placebo chewable tablets

DRUG

Placebo to budesonide inhaler

Placebo inhalation powder

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2004-06-30
Completion
2004-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00092092 on ClinicalTrials.gov