Back to resultsSafety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0476, Montelukast Sodium /Duration of Treatment : 14 Days
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis
Eligibility 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.
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00394160
Brief Title
Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)
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 Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0476, Montelukast Sodium /Duration of Treatment : 14 Days
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 months.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18296556
Citation
Kearns GL, Lu S, Maganti L, Li XS, Migoya E, Ahmed T, Knorr B, Reiss TF. Pharmacokinetics and safety of montelukast oral granules in children 1 to 3 months of age with bronchiolitis. J Clin Pharmacol. 2008 Apr;48(4):502-11. doi: 10.1177/0091270008314251. Epub 2008 Feb 22.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)
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