NCT00963599

Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 907 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 15 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Comparator: montelukast/loratadine	montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks
DRUG	Comparator: montelukast	montelukast 10 mg tablet taken once daily at bed time for 2 weeks
DRUG	Comparator: loratadine	loratadine 10 mg tablet taken once daily at bed time for 2 weeks
DRUG	Comparator: placebo	placebo tablet taken once daily at bed time for 2 weeks

Timeline

• Start date: 1999-09-01
• Primary completion: 1999-11-01
• Completion: 1999-11-01
• First posted: 2009-08-21
• Last updated: 2022-02-09
• Results posted: 2010-06-16