At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,365 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, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis
In Brief
A Phase 3 clinical trial evaluating montelukast sodium, Comparator: cetirizine, and 1 other intervention for Perennial Allergic Rhinitis. Completed, enrolled 1,365 participants.
Detailed Summary
This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPerennial Allergic Rhinitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2001
Primary CompletionMay 2002
First PostedSep 2009
TodayJul 2026
First PostedSep 10, 2009
Enrollment StartNov 1, 2001
Primary CompletionMay 1, 2002
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.8 years ago
Interventions
montelukast sodiumdrug
montelukast 10 mg tablet orally once daily at bedtime for 6 weeks
Comparator: cetirizinedrug
cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks
Comparator: placebodrug
placebo tablet orally once daily at bedtime for 6 weeks