At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,079 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 Over a 4-Week Treatment Period-Fall 2001
In Brief
A Phase 3 clinical trial evaluating montelukast sodium, Comparator: loratadine, and 1 other intervention for Seasonal Allergic Rhinitis. Completed, enrolled 1,079 participants.
Detailed Summary
This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. 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
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2001
Primary CompletionNov 2001
First PostedAug 2009
TodayJul 2026
First PostedAug 21, 2009
Enrollment StartAug 1, 2001
Primary CompletionNov 1, 2001
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.9 years ago
Interventions
montelukast sodiumdrug
montelukast 10 mg tablet orally once daily in the morning for 4 weeks
Comparator: loratadinedrug
loratadine 10 mg tablet orally once daily in the morning for 4 weeks
Comparator: placebodrug
placebo tablet orally once daily in the morning for 4 weeks