Clinical trial NCT01852812: Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2013-05-14
Enrollment: 87
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants Who Experience at Least One Adverse Event (AE)
timeFrame: Up to 14 days after last dose of study drug (Up to 14 weeks)
measure: Percentage of Participants Who Discontinue Study Drug Due to an AE
timeFrame: Up to 12 weeks
measure: Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG
timeFrame: Up to Day 28 after first dose of study drug
measure: Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG
timeFrame: Up to Day 28 after first dose of study drug
measure: Time to Cmax (Tmax) of Montelukast CT and Montelukast OG
timeFrame: Up to Day 28 after first dose of study drug
measure: Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG
timeFrame: Up to Day 28 after first dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.