NCT00700661
Completed
Phase 3
A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years
Overview
- Phase
- Phase 3
- Intervention
- placebo (unspecified)
- Conditions
- Asthma
- Sponsor
- Organon and Co
- Enrollment
- 500
- Primary Endpoint
- asthma episodes in 2 - 5 year old children
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.
Investigators
Eligibility Criteria
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
Arms & Interventions
2
Pbo
Intervention: placebo (unspecified)
1
Drug
Intervention: montelukast
Outcomes
Primary Outcomes
asthma episodes in 2 - 5 year old children
Time Frame: at 12 months
Secondary Outcomes
- the number of treatments and duration of asthma episodes(at 12 months)
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