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)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 1 Year – 15 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Montelukast Oral Granules (OG)	Montelukast 4 mg in one sachet
DRUG	Montelukast Chewable Tablets (CT)	Montelukast 5 mg in one tablet

Timeline

• Start date: 2013-06-07
• Primary completion: 2013-12-24
• Completion: 2013-12-24
• First posted: 2013-05-14
• Last updated: 2024-06-18
• Results posted: 2014-09-29