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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00943683
First received: July 21, 2009
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Asthma
Drug: montelukast sodium
Drug: Comparator: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment [ Time Frame: During the 6 weeks of treatment ] [ Designated as safety issue: Yes ]
    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


Enrollment: 256
Study Start Date: August 2000
Study Completion Date: April 2001
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Montelukast
Drug: montelukast sodium
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
Placebo Comparator: 2
Placebo
Drug: Comparator: Placebo
Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943683

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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00943683     History of Changes
Other Study ID Numbers: 0476-176, MK0476-176, 2009_618
Study First Received: July 21, 2009
Results First Received: July 27, 2009
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014