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

Last updated: June 5, 2024
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Rhinitis, Allergic, Perennial

Allergy

Nasal Obstruction

Treatment

Montelukast

Placebo

Clinical Study ID

NCT01857063
0476-519
132232
  • Ages 10-15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Weight: ≥ 25 kg

  • Height: ≥ 125 cm

  • Able to record symptoms in a diary

  • Has had allergic rhinitis symptoms [Japanese Cedar (JC) pollinosis]

  • Tested positive for JC pollen specific immunoglobulin E (IgE) antibody assay

Exclusion

Exclusion Criteria:

  • Has nasal findings that would interfere with evaluating nasal congestion symptoms

  • Past or present medical history of bronchial asthma

  • Medical history of allergies except allergic rhinitis and has possibility ofdramatically worsening of these symptoms induced by JC pollen exposure

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Montelukast
Phase: 3
Study Start date:
June 10, 2013
Estimated Completion Date:
September 01, 2013

Connect with a study center

  • MSD K.K.

    Chiyoda-Ku, Tokyo, 102-8667
    Japan

    Site Not Available

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