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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: montelukast; Drug: placebo (unspecified)

• Registration Number: NCT00700661
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	montelukast	Drug
2	placebo (unspecified)	Pbo

Primary Outcome Measures

Name	Time	Method
asthma episodes in 2 - 5 year old children	at 12 months

Secondary Outcome Measures

Name	Time	Method
the number of treatments and duration of asthma episodes	at 12 months