Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis
This study has been completed.
Information provided by:
First received: October 27, 2006
Last updated: April 25, 2008
Last verified: April 2008
The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to < 3 months of age with bronchiolitis.
Drug: MK0476, Montelukast Sodium /Duration of Treatment : 14 Days
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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 1 to 3 Months|
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 months.
Secondary Outcome Measures:
- 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 1 to 3 months.
|Study Start Date:||December 2004|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
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