Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)

Phase 2

Completed

• Conditions: Bronchiolitis

• Registration Number: NCT00394160
• Lead Sponsor: Organon and Co

Brief Summary

The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to \< 3 months of age with bronchiolitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Study First Submitted: 2006-10-27
• Study First Submitted QC: 2006-10-27
• Study First Posted: 2006-10-31
• Status Verified: 2022-01
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 months.

Secondary Outcome Measures

Name	Time	Method
To estimate the single-dose population pharmacokinetics, (maximum plasma concentration, time to maximum plasma concentration, and apparent half-life) of montelukast 4-mg oral granules in children aged 1 to 3 months.