A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00700661
First received: June 17, 2008
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.


Condition Intervention Phase
Asthma
Drug: montelukast
Drug: placebo (unspecified)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years

Resource links provided by NLM:


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

Primary Outcome Measures:
  • asthma episodes in 2 - 5 year old children [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the number of treatments and duration of asthma episodes [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: January 2001
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug
Drug: montelukast
One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks
Other Names:
  • MK0476
  • SINGULAIR ®
Placebo Comparator: 2
Pbo
Drug: placebo (unspecified)
Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female between and including the ages of 2 and 5 years
  • Patient was treated with steroids for an asthma episode in the last 3 months
  • Patient was admitted to the hospital or emergency room in the last 3 months
  • Patient is able to chew a tablet

Exclusion Criteria:

  • Patient has been in a research study in the past 4 weeks
  • Patient has visited the emergency room for an asthma episode in the past week
  • Patients has a history of stomach, heart, liver, nerve, kidney or blood disease
  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: NCT00700661

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: NCT00700661     History of Changes
Other Study ID Numbers: 0476-907, MK0476-907, 2007_572
Study First Received: June 17, 2008
Last Updated: June 30, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

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 October 30, 2014