NCT00974571

Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,365 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 15 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	montelukast sodium	montelukast 10 mg tablet orally once daily at bedtime for 6 weeks
DRUG	Comparator: cetirizine	cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks
DRUG	Comparator: placebo	placebo tablet orally once daily at bedtime for 6 weeks

Timeline

• Start date: 2001-11-01
• Primary completion: 2002-05-01
• Completion: 2002-05-01
• First posted: 2009-09-10
• Last updated: 2022-02-03
• Results posted: 2010-06-07