Clinical trial

A Phase III, Open-Label Clinical Trial to Study the Safety and Pharmacokinetics of MK-0476 in Japanese Pediatric Subjects Aged 1 to 15 Years Old With Perennial Allergic Rhinitis

Name

0476-520

Description

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.

Trial arms

Trial start

2013-06-07

Estimated PCD

2013-12-24

Trial end

2013-12-24

Status

Completed

Phase

Early phase I

Treatment

Montelukast Oral Granules (OG)

Montelukast 4 mg in one sachet

Arms:

Montelukast 4 mg OG/1-5 year olds

Montelukast Chewable Tablets (CT)

Montelukast 5 mg in one tablet

Arms:

Montelukast 5 mg CT/10-15 year olds, Montelukast 5 mg CT/6-9 year olds

Size

Primary endpoint

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

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

Up to 12 weeks

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

Up to Day 28 after first dose of study drug

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

Up to Day 28 after first dose of study drug

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

Up to Day 28 after first dose of study drug

Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG

Up to Day 28 after first dose of study drug

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 87, 'type': 'ACTUAL'}}

Updated at

2024-05-10

1 organization

1 product

1 indication

Organization

Organon and Co

Product

Montelukast

Indication

Allergic Rhinitis