At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,577 enrolled
Drug / intervention
Comparator: montelukast +3 moredrug
Likely dose
Comparator: montelukast 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 Effects of Montelukast in Patients With Seasonal Allergic Rhinitis--Spring Study
In Brief
A Phase 3 clinical trial evaluating Comparator: montelukast, Comparator: loratadine, and 2 other interventions for Seasonal Allergic Rhinitis. Completed, enrolled 1,577 participants.
Detailed Summary
This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2000
Primary CompletionMay 2000
First PostedSep 2009
TodayJul 2026
First PostedSep 18, 2009
Enrollment StartMar 1, 2000
Primary CompletionMay 1, 2000
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.8 years ago
Interventions
Comparator: montelukastdrug
10 mg montelukast tablet given once daily at bedtime for 2 weeks
Comparator: loratadinedrug
10 mg loratadine tablet given once daily at bedtime for 2 weeks
Comparator: placebodrug
placebo tablet given once daily at bedtime for 2 weeks
Comparator: montelukast/loratadinedrug
montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks