At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 829 enrolled
Drug / intervention
montelukast sodium +2 moredrug
Likely dose
montelukast sodium 10 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 Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Fall Study
In Brief
A Phase 3 clinical trial evaluating montelukast sodium, Comparator: loratadine, and 1 other intervention for Seasonal Allergic Rhinitis. Completed, enrolled 829 participants.
Detailed Summary
A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2000
Primary CompletionOct 2000
Study CompletionNov 2000
First PostedAug 2009
TodayJul 2026
First PostedAug 17, 2009
Enrollment StartAug 1, 2000
Primary CompletionOct 1, 2000
Study CompletionNov 1, 2000
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.9 years ago
Interventions
montelukast sodiumdrug
montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks
Comparator: loratadinedrug
loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks
Comparator: placebodrug
placebo tablet, taken orally once daily at bed time for 2 weeks