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

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

Completed

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

Drug

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

Comparator: placebo

Drug

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

Primary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Aged 6 to 24 Months With Asthma

Important dates

Study start: 2000
Primary completion: 2001
Study completion: 2001
First posted: Jul 22, 2009
Registry last updated: Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed