Clinical trial NCT01857063: Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)
Official title: A Phase III, Double-Blind, Randomized, Placebo-Controlled Cross-over Clinical Trial to Study the Efficacy and Safety of MK-0476 in Japanese Pediatric Subjects With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2013-05-20
Enrollment: 220
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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 of dramatically worsening of these symptoms induced by JC pollen exposure

Primary outcomes:
measure: Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure
timeFrame: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
measure: Percentage of Participants Who Experience at Least One Adverse Event
timeFrame: Up to 5 weeks
Secondary outcomes:
measure: Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure
timeFrame: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
measure: Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure
timeFrame: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
measure: Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure
timeFrame: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
measure: Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure
timeFrame: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
measure: Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
timeFrame: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
measure: Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
timeFrame: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
measure: Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
timeFrame: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
measure: Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
timeFrame: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
measure: Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
timeFrame: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
Other outcomes:
Locations:
Study officials:
References:
citation: 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.