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

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: montelukast sodium

• Registration Number: NCT00968149
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2001-06
• Study Completion: 2001-07
• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-27
• Study First Posted: 2009-08-28
• Results First Submitted: 2009-09-15
• Results First Submitted QC: 2009-11-11
• Results First Posted: 2009-12-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 413

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	montelukast sodium	Montelukast

Primary Outcome Measures

Name	Time	Method
Number of Patients With Clinical Adverse Experiences (CAEs)	2 weeks	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

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Drug-related LAEs	2 weeks
Number of Patients With Serious CAEs	2 weeks	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
Number of Patients With Drug-related CAEs	2 weeks	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Number of Patients Who Were Discontinued Due to CAEs	2 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs)	2 weeks	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
Number of Patients With Serious LAEs	2 weeks	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
Number of Patients Who Were Discontinued Due to LAEs	2 weeks