Back to resultsPK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK-0476, montelukast sodium
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis
Eligibility Criteria
Inclusion Criteria :
- Active bronchiolitis or a history of bronchiolitis and asthma-like symptoms
Exclusion Criteria :
- A history of any significant illness that will pose additional risk to the patient
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Montelukast sodium
Arm Description
Participants receive montelukast sodium for 14 days.
Outcomes
Primary Outcome Measures
To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 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 3 to 6 months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00394069
Brief Title
PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
Double
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Montelukast sodium
Arm Type
Experimental
Arm Description
Participants receive montelukast sodium for 14 days.
Intervention Type
Drug
Intervention Name(s)
MK-0476, montelukast sodium
Intervention Description
Duration of Treatment: 14 Days
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months.
Time Frame
14 days
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 3 to 6 months.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria :
Active bronchiolitis or a history of bronchiolitis and asthma-like symptoms
Exclusion Criteria :
A 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
16707408
Citation
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.
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
PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)
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