PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)
NCT ID: NCT00394069
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2003-07-31
2003-12-31
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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Montelukast sodium
Participants receive montelukast sodium for 14 days.
MK-0476, montelukast sodium
Duration of Treatment: 14 Days
Interventions
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MK-0476, montelukast sodium
Duration of Treatment: 14 Days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Months
6 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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Knorr B, Maganti L, Ramakrishnan R, Tozzi CA, Migoya E, Kearns G. Pharmacokinetics and safety of montelukast in children aged 3 to 6 months. J Clin Pharmacol. 2006 Jun;46(6):620-7. doi: 10.1177/0091270006288324.
Other Identifiers
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2006_545
Identifier Type: -
Identifier Source: secondary_id
0476-268
Identifier Type: -
Identifier Source: org_study_id
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