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

Organon

Status: Completed

Conditions: Asthma

Treatments: Drug: montelukast sodium; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00943683

MK0476-176

2009_618

0476-176

Details and patient eligibility

About

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

Enrollment: 256 patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Montelukast

Treatment:

Drug: montelukast sodium

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo