NCT00394160

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2006

Completed
Last Updated

August 15, 2024

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

October 27, 2006

Last Update Submit

August 12, 2024

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 months.

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 1 to 3 months.

Interventions

MK0476, Montelukast Sodium /Duration of Treatment : 14 DaysDRUG

Eligibility Criteria

Age1 Month - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Active bronchiolitis and a history of bronchiolitis and asthma-like symptoms.

You may not qualify if:

  • Anemia or history of any significant illness that will pose additional risk to the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 18296556BACKGROUND

MeSH Terms

Conditions

Bronchiolitis

Interventions

montelukastDuration of Therapy

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
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

December 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

August 15, 2024

Record last verified: 2022-01