PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)
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
2 other identifiers
interventional
14
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2003
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 27, 2006
CompletedFirst Posted
Study publicly available on registry
October 31, 2006
CompletedAugust 14, 2024
February 1, 2022
5 months
October 27, 2006
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months.
14 days
Secondary Outcomes (1)
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.
24 hours
Study Arms (1)
Montelukast sodium
EXPERIMENTALParticipants receive montelukast sodium for 14 days.
Interventions
Eligibility Criteria
You may qualify if:
- Active bronchiolitis or a history of bronchiolitis and asthma-like symptoms
You may not qualify if:
- A history of any significant illness that will pose additional risk to the patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
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.
PMID: 16707408BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2006
First Posted
October 31, 2006
Study Start
July 1, 2003
Primary Completion
December 1, 2003
Study Completion
December 1, 2003
Last Updated
August 14, 2024
Record last verified: 2022-02