Status:
COMPLETED
Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
2-5 years
Phase:
PHASE3
Brief Summary
A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.
Eligibility Criteria
Inclusion
- Patient has history of physician diagnosed asthma
- Patient is in otherwise good stable health
- Patient is able to chew a tablet
Exclusion
- Patient is hospitalized
- Patient and/or parent of guardian intends to move or vacation away from home during the course of the study
- Patient had any major surgical procedure within 4 weeks before the study
- Patient had active sinus disease within 3 weeks before the study
- Patient had required intubation for asthma in the past
- Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study
- Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study
Key Trial Info
Start Date :
December 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2001
Estimated Enrollment :
689 Patients enrolled
Trial Details
Trial ID
NCT00968201
Start Date
December 1 1997
End Date
March 1 2001
Last Update
February 3 2022
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