PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)

Phase 2

Completed

• Conditions: Bronchiolitis
• Interventions: Drug: MK-0476, montelukast sodium

• Registration Number: NCT00394069
• 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 3 to 6 months of age with bronchiolitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Study First Submitted: 2006-10-27
• Study First Submitted QC: 2006-10-27
• Study First Posted: 2006-10-31
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Montelukast sodium	MK-0476, montelukast sodium	Participants receive montelukast sodium for 14 days.

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months.	14 days

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 3 to 6 months.	24 hours