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PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00394069
First received: October 27, 2006
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  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 2

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:

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
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
  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:

ClinicalTrials.gov Identifier: NCT00394069     History of Changes
Other Study ID Numbers: 2006_545
Study First Received: October 27, 2006
Last Updated: May 21, 2013
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 May 23, 2013