At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 413 enrolled
Drug / intervention
montelukast sodium +1 moredrug
Likely dose
montelukast sodium 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 Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Age 2 Through 14 Years With Seasonal Allergic Rhinitis
In Brief
A Phase 3 clinical trial evaluating montelukast sodium and Comparator: Placebo for Seasonal Allergic Rhinitis. Completed, enrolled 413 participants.
Detailed Summary
This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2001
Primary CompletionJun 2001
Study CompletionJul 2001
First PostedAug 2009
TodayJul 2026
First PostedAug 28, 2009
Enrollment StartMar 1, 2001
Primary CompletionJun 1, 2001
Study CompletionJul 1, 2001
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.8 years ago
Interventions
montelukast sodiumdrug
one montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years
Comparator: Placebodrug
one placebo chewable tablet daily at bed time for 2 weeks