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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: Montelukast Oral Granules (OG)
* Drug: Montelukast Chewable Tablets (CT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast 4 mg OG/1-5 year olds<br>Participants receive montelukast 4 mg OG in one sachet orally (PO) once daily (QD) at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total) | Drug: Montelukast Oral Granules (OG)<br>* Montelukast 4 mg in one sachet<br>|
| Experimental: Montelukast 5 mg CT/6-9 year olds<br>Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks | Drug: Montelukast Chewable Tablets (CT)<br>* Montelukast 5 mg in one tablet<br>|
| Experimental: Montelukast 5 mg CT/10-15 year olds<br>Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks | Drug: Montelukast Chewable Tablets (CT)<br>* Montelukast 5 mg in one tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Up to Day 28 after first dose of study drug | 
| Time to Cmax (Tmax) 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. | Up to Day 28 after first dose of study drug | 
| Apparent Elimination Half-life (t1/2) 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. | Up to Day 28 after first dose of study drug | 
| 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. | Up to 14 days after last dose of study drug (Up to 14 weeks) |