Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
NCT ID: NCT00943683
Last Updated: 2022-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
256 participants
INTERVENTIONAL
2000-08-31
2001-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Montelukast
montelukast sodium
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
2
Placebo
Comparator: Placebo
Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
Interventions
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montelukast sodium
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
Comparator: Placebo
Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* Patient has been fed solid foods for at least 1 month
* Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit
* Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines
Exclusion Criteria
6 Months
24 Months
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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van Adelsberg J, Moy J, Wei LX, Tozzi CA, Knorr B, Reiss TF. Safety, tolerability, and exploratory efficacy of montelukast in 6- to 24-month-old patients with asthma. Curr Med Res Opin. 2005 Jun;21(6):971-9. doi: 10.1185/030079905X48456.
Other Identifiers
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MK0476-176
Identifier Type: -
Identifier Source: secondary_id
2009_618
Identifier Type: -
Identifier Source: secondary_id
0476-176
Identifier Type: -
Identifier Source: org_study_id
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