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Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)

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ClinicalTrials.gov Identifier: NCT00943683
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : June 17, 2010
Last Update Posted : July 15, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.

Condition or disease Intervention/treatment
Asthma Drug: montelukast sodium Drug: Comparator: Placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Aged 6 to 24 Months With Asthma
Study Start Date : August 2000
Primary Completion Date : February 2001
Study Completion Date : February 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: montelukast sodium
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
Placebo Comparator: 2
Drug: Comparator: Placebo
Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks

Primary Outcome Measures :
  1. Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment [ Time Frame: During the 6 weeks of treatment ]
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient is in good, stable health
  • Patient has been fed solid foods for at least 1 month
  • Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit
  • Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines

Exclusion Criteria:

  • Patient was hospitalized at the start of the study or required a visit to the emergency room due to asthma with in past 2 weeks

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): NCT00943683

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

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00943683     History of Changes
Other Study ID Numbers: 0476-176
First Posted: July 22, 2009    Key Record Dates
Results First Posted: June 17, 2010
Last Update Posted: July 15, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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