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NCT00394160 Clinical Trial

Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)

Bronchiolitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00394160
Other study ID # 0476-297
Secondary ID 2006_544
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2004
Est. completion date October 2005

Study information
Verified date January 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender All
Age group 1 Month to 3 Months
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0476, Montelukast Sodium /Duration of Treatment : 14 Days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 months.
Secondary 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.
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