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

Phase 3

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: Montelukast Oral Granules (OG); Drug: Montelukast Chewable Tablets (CT)

• Registration Number: NCT01852812
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-09
• Study First Posted: 2013-05-14
• Study Start: 2013-06-07
• Primary Completion: 2013-12-24
• Study Completion: 2013-12-24
• Results First Submitted: 2014-09-25
• Results First Submitted QC: 2014-09-25
• Results First Posted: 2014-09-29
• Status Verified: 2022-02
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Montelukast 4 mg OG/1-5 year olds	Montelukast Oral Granules (OG)	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)
Montelukast 5 mg CT/6-9 year olds	Montelukast Chewable Tablets (CT)	Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
Montelukast 5 mg CT/10-15 year olds	Montelukast Chewable Tablets (CT)	Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks

Primary Outcome Measures

Name	Time	Method
Time to Cmax (Tmax) of Montelukast CT and Montelukast OG	Up to Day 28 after first dose of study drug	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.
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)	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.
Percentage of Participants Who Discontinue Study Drug Due to an AE	Up to 12 weeks	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.
Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG	Up to Day 28 after first dose of study drug	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.
Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG	Up to Day 28 after first dose of study drug	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.
Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG	Up to Day 28 after first dose of study drug	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.