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

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: October 27, 2006
Last updated: April 25, 2008
Last verified: April 2008

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
Drug: MK0476, Montelukast Sodium /Duration of Treatment : 14 Days
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 1 to 3 Months

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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)

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

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 identifier: NCT00394160

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

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

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses processed this record on April 17, 2014