At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 87 enrolled
Drug / intervention
Montelukast Oral Granules (OG) +1 moredrug
Likely dose
Montelukast Oral Granules (OG) 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Montelukast Oral Granules (OG) and Montelukast Chewable Tablets (CT) for Perennial Allergic Rhinitis. Completed, enrolled 87 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPerennial Allergic Rhinitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJun 2013
Primary CompletionDec 2013
TodayJul 2026
First PostedMay 14, 2013
Enrollment StartJun 7, 2013
Primary CompletionDec 24, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.1 years ago
Interventions
Montelukast Oral Granules (OG)drug
Montelukast 4 mg in one sachet
Montelukast Chewable Tablets (CT)drug
Montelukast 5 mg in one tablet