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

Organon and Co12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bronchiolitis

Interventions

MK0476, Montelukast Sodium /Duration of Treatment : 14 DaysDRUG

Eligibility

Sex: ALLMin age: 1 MonthMax age: 3 Months

Medical Language ↔ Plain English

Inclusion Criteria : * Active bronchiolitis and a history of bronchiolitis and asthma-like symptoms. Exclusion Criteria : * Anemia or history of any significant illness that will pose additional risk to the patient.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.