Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis

This study has been completed.

First Received: October 27, 2006 Last Updated: April 25, 2008 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00394160

Purpose

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.

Condition	Intervention	Phase
Bronchiolitis	Drug: MK0476, Montelukast Sodium /Duration of Treatment : 14 Days	Phase II

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
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

Further study details as provided by Merck:

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.

Enrollment:	12
Study Start Date:	December 2004
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	1 Month to 3 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394160

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

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. Epub 2008 Feb 22.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_544
Study First Received:	October 27, 2006
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00394160 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bronchial Diseases
Bronchiolitis
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Hormones
Leukotriene Antagonists

Montelukast
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Bronchitis

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Bronchiolitis
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions

Leukotriene Antagonists
Montelukast
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Lung Diseases
Bronchitis

ClinicalTrials.gov processed this record on May 07, 2009