A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: montelukast; Drug: placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00700661

0476-907

MK0476-907

2007_572

Details and patient eligibility

About

A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.

Enrollment: 500 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female between and including the ages of 2 and 5 years
• Patient was treated with steroids for an asthma episode in the last 3 months
• Patient was admitted to the hospital or emergency room in the last 3 months
• Patient is able to chew a tablet

Exclusion criteria

• Patient has been in a research study in the past 4 weeks
• Patient has visited the emergency room for an asthma episode in the past week
• Patients has a history of stomach, heart, liver, nerve, kidney or blood disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Drug

Treatment:

Drug: montelukast

2

Placebo Comparator group

Description:

Pbo

Treatment:

Drug: placebo (unspecified)