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

NCT ID: NCT01852812

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-07
• Study Completion Date: 2013-12-24

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.

Conditions

Perennial Allergic Rhinitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Montelukast 4 mg OG/1-5 year olds

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)

Group Type: EXPERIMENTAL

Montelukast Oral Granules (OG)

Intervention Type: DRUG

Montelukast 4 mg in one sachet

Montelukast 5 mg CT/6-9 year olds

Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks

Group Type: EXPERIMENTAL

Montelukast Chewable Tablets (CT)

Intervention Type: DRUG

Montelukast 5 mg in one tablet

Montelukast 5 mg CT/10-15 year olds

Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks

Group Type: EXPERIMENTAL

Montelukast Chewable Tablets (CT)

Intervention Type: DRUG

Montelukast 5 mg in one tablet

Interventions

Montelukast Oral Granules (OG)

Montelukast 4 mg in one sachet

Intervention Type: DRUG

Montelukast Chewable Tablets (CT)

Montelukast 5 mg in one tablet

Intervention Type: 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Okubo K, Inoue Y, Numaguchi H, Tanaka K, Saito I, Oshima N, Matsumoto Y, Prohn M, Mehta A, Nishida C, Philip G. Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial. J Drug Assess. 2016 Sep 19;5(1):6-14. doi: 10.1080/21556660.2016.1209507. eCollection 2016.

Reference Type: RESULT

PMID: 27785374 (View on PubMed)

Hashiguchi K, Okubo K, Inoue Y, Numaguchi H, Tanaka K, Oshima N, Mehta A, Nishida C, Saito I, Philip G. Evaluation of Montelukast for the Treatment of Children With Japanese Cedar Pollinosis Using an Artificial Exposure Chamber (OHIO Chamber). Allergy Rhinol (Providence). 2018 Jul 13;9:2152656718783599. doi: 10.1177/2152656718783599. eCollection 2018 Jan-Dec.

Reference Type: DERIVED

PMID: 30027002 (View on PubMed)

Other Identifiers

132233

Identifier Type: REGISTRY

Identifier Source: secondary_id

0476-520

Identifier Type: -

Identifier Source: org_study_id