At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 220 enrolled
Drug / intervention
Montelukast +1 moredrug
Likely dose
Montelukast 5 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, Double-Blind, Randomized, Placebo-Controlled Cross-over Clinical Trial to Study the Efficacy and Safety of MK-0476 in Japanese Pediatric Subjects With Seasonal Allergic Rhinitis
In Brief
A Phase 3 clinical trial evaluating Montelukast and Placebo for Seasonal Allergic Rhinitis. Completed, enrolled 220 participants.
Detailed Summary
This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that montelukast is superior to placebo in the treatment of nasal symptoms in SAR.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJun 2013
Primary CompletionSep 2013
TodayJul 2026
First PostedMay 20, 2013
Enrollment StartJun 10, 2013
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.1 years ago
Interventions
Montelukastdrug
Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days
Placebodrug
Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days