Status:
COMPLETED
A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
2-14 years
Phase:
PHASE3
Brief Summary
This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.
Eligibility Criteria
Inclusion
- Patient has a history of allergic rhinitis symptoms which flare up during the study season
- Patient is a non-smoker
- Patient is in otherwise good health
- Patient is able to chew a tablet
Exclusion
- Patient is hospitalized
- Patient is pregnant or nursing mother, or \<8 weeks post partum
- Patient and/or parent intend to move or vacation away from home during the trial
- Patient has had a major surgical procedure within 4 weeks of the prestudy visit
- Patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study
- Patient has an upper respiratory, eye, or sinus infection, or a history of any of these within 3 weeks prior to study
- Patient has a recent history of a psychiatric disorder or attention deficit hyperactivity disorder
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2001
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT00968149
Start Date
March 1 2001
End Date
July 1 2001
Last Update
February 3 2022
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