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

Organon and Co413 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

413

Conditions

Seasonal Allergic Rhinitis

Interventions

montelukast sodiumDRUG

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

Comparator: PlaceboDRUG

one placebo chewable tablet daily at bed time for 2 weeks

Eligibility

Sex: ALLMin age: 2 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 2 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 2 weeks

Number of Patients Who Were Discontinued Due to CAEs

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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