Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis
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 1 to < 3 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 1 to 3 Months
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Primary outcome: To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 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 1 to 3 months.
Eligibility
Minimum age: 1 Month.
Maximum age: 3 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria :
- Active bronchiolitis and a history of bronchiolitis and asthma-like symptoms.
Exclusion Criteria :
- Anemia or history of any significant illness that will pose additional risk to the patient.
Locations and Contacts
Additional Information
Starting date:
December 2004
Last updated: October 27, 2006
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