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

NCT01857063 | Completed Phase 3 Results

• 2 other identifiers: 0476-519132232
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure

  The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. Participants completed a questionnaire about their nasal symptoms. Score ranged from 0 to 4 for each of the three nasal symptoms, with a total possible score ranging from 0 to 12 and a higher score indicating more severe nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to Japanes cedar (JC) pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.

  Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

• Percentage of Participants Who Experience at Least One Adverse Event

  An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence adverse events for up to 14 days after last dose of study drug. Analysis was done by study drug as taken.

  Up to 5 weeks

Secondary Outcomes (9)

• Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure

  Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

• Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure

  Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

• Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure

  Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

• Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure

  Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

• Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room

  Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period

Study Arms (2)

Montelukast/Placebo

EXPERIMENTAL

Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.

Drug: Montelukast; Drug: Placebo

Placebo/Montelukast

EXPERIMENTAL

Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.

Drug: Montelukast; Drug: Placebo

Interventions

Montelukast DRUG

Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days

Also known as: montelukast sodium

Montelukast/Placebo; Placebo/Montelukast

Placebo DRUG

Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days

Montelukast/Placebo; Placebo/Montelukast

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 of dramatically worsening of these symptoms induced by JC pollen exposure

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 30027002 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

montelukast

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 20, 2013
• Study Start: June 10, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 17, 2024
• Results First Posted: May 26, 2014

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share