NCT00700661CompletedPhase 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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 500
- Primary Endpoint
- asthma episodes in 2 - 5 year old children
Study Overview
Brief Summary
A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 2 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Placebo Comparator
Pbo
Intervention: placebo (unspecified) (Drug)
1
Experimental
Drug
Intervention: montelukast (Drug)
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)
Investigators
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