Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)

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

Phase

3

Condition

Common Cold

Allergy

Rhinitis, Allergic, Perennial

Treatment

Montelukast Oral Granules (OG)

Montelukast Chewable Tablets (CT)

Clinical Study ID

NCT01852812
0476-520
132233
  • Ages 1-15
  • All Genders

Study Summary

This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The primary hypothesis of this study is that montelukast oral granules (OG) and chewable tablets (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with PAR.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Weight ≥8 kg

  • Diagnosis of PAR and has symptoms of PAR at Visit 1

Exclusion

Exclusion Criteria:

  • Past or present medical history of asthma

  • Diagosis of acute rhinitis, simple rhinitis, rhinitis congestive, rhinitis atrophic,sinusitis with purulent nasal discharge, rhinitis medicamentosa or nonallergicrhinitis (e.g. vasomotor rhinitis, eosinophilic rhinitis)

  • Started hyposensitization therapy or non-specific immunotherapy within 6 monthsprior to Visit 1

  • Medical history of inferior concha mucosal resection, submucous resection ofinferior turbinates or other surgery aimed at reduction and/or modulation of nasalmucosa (including electrocoagulation, cryoextraction or application oftrichloroacetic acid)

  • Clinically significant, active disease of the cardiovascular or hematologic systemsor uncontrolled hypertension (1 to 5 year olds: >120/70 mmHg; 6 to 9 year olds: >130/80 mmHg; 10 to 15 year olds: >140/85 mmHg)

  • Medical history of stunted growth

  • Serious drug allergy

  • Treated with other clinical study drug within 3 months prior to Visit 1

Study Design

Total Participants: 87
Treatment Group(s): 2
Primary Treatment: Montelukast Oral Granules (OG)
Phase: 3
Study Start date:
June 07, 2013
Estimated Completion Date:
December 24, 2013

Connect with a study center

  • MSD K.K.

    Chiyoda-Ku, Tokyo, 102-8667
    Japan

    Site Not Available

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