Status:
COMPLETED
Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)
Lead Sponsor:
Organon and Co
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
10-15 years
Phase:
PHASE3
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 stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01857063
Start Date
June 10 2013
End Date
September 1 2013
Last Update
June 17 2024
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