PK Study in 3- to 6- Month-Old Children
Information source: Merck
Information obtained from ClinicalTrials.gov on August 06, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchiolitis
Intervention: MK0476, montelukast sodium / Duration of Treatment: 14 Days (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 3 to 6 months of age with bronchiolitis.
Clinical Details
Official title:
A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 3 to 6 Months
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months.
Secondary outcome: To estimate the single-dose population pharmacokinetics, maximum plasma concentration, time to maximum plasma concentration, and apparent half-life of montelukast 4-mg oral granules in children aged 3 to 6 months.
Eligibility
Minimum age: 3 Months.
Maximum age: 6 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria :
- Active bronchiolitis or a history of bronchiolitis and asthmas-like symptoms
Exclusion Criteria :
- A history of any significant illness that will pose additional risk to the patient
Locations and Contacts
Additional Information
Related publications: 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.
Starting date:
June 2003
Last updated: January 10, 2007
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