A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)

Study Overview
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Brief Summary
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This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.

Official Title
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A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Age 2 Through 14 Years With Seasonal Allergic Rhinitis

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: montelukast sodium
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a history of allergic rhinitis symptoms which flare up during the study season Patient is a non-smoker Patient is in otherwise good health Patient is able to chew a tablet Exclusion Criteria: Patient is hospitalized Patient is pregnant or nursing mother, or <8 weeks post partum Patient and/or parent intend to move or vacation away from home during the trial Patient has had a major surgical procedure within 4 weeks of the prestudy visit Patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study Patient has an upper respiratory, eye, or sinus infection, or a history of any of these within 3 weeks prior to study Patient has a recent history of a psychiatric disorder or attention deficit hyperactivity disorder

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Montelukast | Drug: montelukast sodium<br>* one montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Comparator: Placebo<br>* one placebo chewable tablet daily at bed time for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Clinical Adverse Experiences (CAEs) | A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Serious CAEs | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | 2 weeks | 
| Number of Patients With Drug-related CAEs | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | 2 weeks | 
| Number of Patients Who Were Discontinued Due to CAEs |  | 2 weeks | 
| Number of Patients With Laboratory Adverse Experiences (LAEs) | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 2 weeks | 
| Number of Patients With Serious LAEs | Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | 2 weeks | 
| Number of Patients With Drug-related LAEs |  | 2 weeks | 
| Number of Patients Who Were Discontinued Due to LAEs |  | 2 weeks |