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

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ClinicalTrials.gov Identifier: NCT00394069
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Bronchiolitis Drug: MK-0476, montelukast sodium Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : July 2003
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Montelukast sodium
Participants receive montelukast sodium for 14 days.
Drug: MK-0476, montelukast sodium
Duration of Treatment: 14 Days



Primary Outcome Measures :
  1. To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months. [ Time Frame: 14 days ]

Secondary Outcome Measures :
  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 3 to 6 months. [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria :

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

Exclusion Criteria :

  • A history of any significant illness that will pose additional risk to the patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394069


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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00394069     History of Changes
Other Study ID Numbers: 0476-268
2006_545
First Posted: October 31, 2006    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action