NCT00963469

Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,079 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 15 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	montelukast sodium	montelukast 10 mg tablet orally once daily in the morning for 4 weeks
DRUG	Comparator: loratadine	loratadine 10 mg tablet orally once daily in the morning for 4 weeks
DRUG	Comparator: placebo	placebo tablet orally once daily in the morning for 4 weeks

Timeline

• Start date: 2001-08-01
• Primary completion: 2001-11-01
• Completion: 2001-11-01
• First posted: 2009-08-21
• Last updated: 2022-02-03
• Results posted: 2010-06-09