PK Study in 3- to 6- Month-Old Children - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00394069

Purpose

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.

Condition	Intervention	Phase
Bronchiolitis	Drug: MK0476, montelukast sodium / Duration of Treatment: 14 Days	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

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.

Estimated Enrollment:	12
Study Start Date:	June 2003

Eligibility

Ages Eligible for Study:	3 Months to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria :

Active bronchiolitis or a history of bronchiolitis and asthmas-like symptoms

Exclusion Criteria :

A 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: NCT00394069

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00394069 History of Changes
Other Study ID Numbers:	2006_545
Study First Received:	October 27, 2006
Last Updated:	January 10, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012