An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

Phase 3 Completed 1375 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.

Timeline

Start: 2004-11
Primary completion: 2005-04
Completion: 2005-04

Outcome

Met primary endpoint

paper Montelukast 5mg and 10mg were non-inferior to pranlukast 450mg in the change from the baseline in the composite nasal symptoms scores. PMID 18946234 ↗

Publications

Results Okubo K, Baba K. A double-blind non-inferiority clinical study of montelukast, a cysteinyl leukotriene receptor 1 antagonist, compared with pranlukast in patients with seasonal allergic rhinitis. Allergol Int. 2008 Dec;57(4):383-90. doi: 10.2332/allergolint.O-08-533. Epub 2008 Nov 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Montelukast	Other / unclassified	5 mg	Oral
Subject	Montelukast	Other / unclassified	10 mg	Oral
Comparator	Pranlukast	Small molecule	225 mg	Oral