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

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

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

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: montelukast sodium; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 413
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Comparator: Placebo; one placebo chewable tablet daily at bed time for 2 weeks
Experimental: 1; Montelukast	Drug: montelukast sodium; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Bisgaard H, Skoner D, Boza ML, Tozzi CA, Newcomb K, Reiss TF, Knorr B, Noonan G. Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions. Pediatr Pulmonol. 2009 Jun;44(6):568-79. doi: 10.1002/ppul.21018.

Study record dates

Study Major Dates

• Study Start: March 1, 2001
• Primary Completion (Actual): June 1, 2001
• Study Completion (Actual): July 1, 2001

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: August 27, 2009
• First Posted (Estimate): August 28, 2009

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: 0476-219; MK0476-219; 2009_652