Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)

Phase 3 Completed 220 enrolled Organon and Co

RandomizedCrossoverTriple-blindTreatment

Summary

This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that montelukast is superior to placebo in the treatment of nasal symptoms in SAR.

Timeline

Start: 2013-06-10
Primary completion: 2013-09-01
Completion: 2013-09-01

Outcome

Missed primary endpoint

registry analysis (unspecified test); Montelukast vs Placebo; p = 0.913; Difference in Least Squares (LS) Means -0.01 (95% CI -0.11 to 0.10) NCT01857063 ↗

paper Although montelukast was well tolerated, this study did not demonstrate a treatment difference between active drug and placebo PMID 30027002 ↗

Publications

Results Hashiguchi K, Okubo K, Inoue Y, Numaguchi H, Tanaka K, Oshima N, Mehta A, Nishida C, Saito I, Philip G. Evaluation of Montelukast for the Treatment of Children With Japanese Cedar Pollinosis Using an Artificial Exposure Chamber (OHIO Chamber). Allergy Rhinol (Providence). 2018 Jul 13;9:2152656718783599. doi: 10.1177/2152656718783599. eCollection 2018 Jan-Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Montelukast	Other / unclassified	5 mg	Oral