Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)

Organon and Co87 enrolled

Overview

This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The primary hypothesis of this study is that montelukast oral granules (OG) and chewable tablets (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with PAR.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Perennial Allergic Rhinitis

Interventions

Montelukast Oral Granules (OG)DRUG

Montelukast 4 mg in one sachet

Montelukast Chewable Tablets (CT)DRUG

Montelukast 5 mg in one tablet

Eligibility

Sex: ALLMin age: 1 YearMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Weight ≥8 kg * Diagnosis of PAR and has symptoms of PAR at Visit 1 Exclusion Criteria: * Past or present medical history of asthma * Diagosis of acute rhinitis, simple rhinitis, rhinitis congestive, rhinitis atrophic, sinusitis with purulent nasal discharge, rhinitis medicamentosa or nonallergic rhinitis (e.g. vasomotor rhinitis, eosinophilic rhinitis) * Started hyposensitization therapy or non-specific immunotherapy within 6 months prior to Visit 1 * Medical history of inferior concha mucosal resection, submucous resection of inferior turbinates or other surgery aimed at reduction and/or modulation of nasal mucosa (including electrocoagulation, cryoextraction or application of trichloroacetic acid) * Clinically significant, active disease of the cardiovascular or hematologic systems or uncontrolled hypertension (1 to 5 year olds: \>120/70 mmHg; 6 to 9 year olds: \>130/80 mmHg; 10 to 15 year olds: \>140/85 mmHg) * Medical history of stunted growth * Serious drug allergy * Treated with other clinical study drug within 3 months prior to Visit 1

Outcomes

Primary Outcomes

Percentage of Participants Who Experience at Least One Adverse Event (AE)

An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Participants were monitored for the occurrence of AEs for up to 14 days after last dose of study drug (up to a total of 14 weeks). AEs were reported based on the dose of study drug participants received.

Time frame: Up to 14 days after last dose of study drug (Up to 14 weeks)

Percentage of Participants Who Discontinue Study Drug Due to an AE

An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Discontinuations due to an AE were reported based on the dose of study drug participants received.

Time frame: Up to 12 weeks

Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG

Blood samples for pharmacokinetic (PK) assessments were collected at either 1 hour (h) or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.

Time frame: Up to Day 28 after first dose of study drug

Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG

Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.

Time frame: Up to Day 28 after first dose of study drug

Time to Cmax (Tmax) of Montelukast CT and Montelukast OG

Data from ClinicalTrials.gov

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