Clinical Trials Directory

Trials / Completed

CompletedNCT00972738

Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

A Multi-Center, Double-blind, Randomized, Parallel-Group Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Spring 2001 Study

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
1,214 (actual)
Sponsor
Organon and Co · Industry
Sex
All
Age
15 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGmontelukast sodiumMontelukast 10-mg tablet orally once daily at bedtime for 2 weeks.
DRUGComparator: loratadineLoratadine 10-mg tablet orally once daily at bedtime for 2 weeks.
DRUGComparator: Placeboplacebo tablet orally once daily at bedtime for 2 weeks

Timeline

Start date
2001-04-01
Primary completion
2001-07-01
Completion
2001-07-01
First posted
2009-09-07
Last updated
2022-02-03
Results posted
2010-06-16

Source: ClinicalTrials.gov record NCT00972738. Inclusion in this directory is not an endorsement.