Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)
NCT ID: NCT01857063
Last Updated: 2024-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2013-06-10
2013-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Montelukast/Placebo
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.
Montelukast
Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days
Placebo
Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days
Placebo/Montelukast
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.
Montelukast
Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days
Placebo
Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days
Interventions
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Montelukast
Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days
Placebo
Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
15 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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References
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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.
Other Identifiers
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132232
Identifier Type: REGISTRY
Identifier Source: secondary_id
0476-519
Identifier Type: -
Identifier Source: org_study_id
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