At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,214 enrolled
Drug / intervention
montelukast sodium +2 moredrug
Likely dose
Not stated in 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 Multi-Center, Double-blind, Randomized, Parallel-Group Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Spring 2001 Study
In Brief
A Phase 3 clinical trial evaluating montelukast sodium, Comparator: loratadine, and 1 other intervention for Seasonal Allergic Rhinitis. Completed, enrolled 1,214 participants.
Detailed Summary
This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2001
Primary CompletionJul 2001
First PostedSep 2009
TodayJul 2026
First PostedSep 7, 2009
Enrollment StartApr 1, 2001
Primary CompletionJul 1, 2001
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.8 years ago
Interventions
montelukast sodiumdrug
Montelukast 10-mg tablet orally once daily at bedtime for 2 weeks.
Comparator: loratadinedrug
Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.
Comparator: Placebodrug
placebo tablet orally once daily at bedtime for 2 weeks