Clinical trial

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

Name

0476-519

Description

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.

Trial arms

Trial start

2013-06-10

Estimated PCD

2013-09-01

Trial end

2013-09-01

Status

Completed

Phase

Early phase I

Treatment

Montelukast

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

Arms:

Montelukast/Placebo, Placebo/Montelukast

Other names:

montelukast sodium

Placebo

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

Arms:

Montelukast/Placebo, Placebo/Montelukast

Size

220

Primary endpoint

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

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

Up to 5 weeks

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 220, 'type': 'ACTUAL'}}

Updated at

2024-05-10

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug