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

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Drug: montelukast sodium

• Registration Number: NCT00943683
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Primary Completion: 2001-02
• Study Completion: 2001-02
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Results First Submitted: 2009-07-27
• Results First Submitted QC: 2010-05-18
• Results First Posted: 2010-06-17
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	montelukast sodium	Montelukast

Primary Outcome Measures

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