A Study of MK0476 Compared With Placebo in Pediatric Patients With Chronic Asthma

This study has been withdrawn prior to enrollment.
(Based on input from regulatory agencies, it is not necessary to conduct this study. An ongoing study was sufficient for regulatory purposes.)
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00540839
First received: October 4, 2007
Last updated: October 6, 2009
Last verified: October 2009
  Purpose

A study to determine the effects of MK0476 on pediatric patient with chronic asthma compared with placebo.


Condition Intervention Phase
Asthma, Bronchial
Drug: montelukast sodium
Drug: Comparator: placebo (unspecified)
Phase 3

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 Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Improvement of chronic (long-lasting) asthma in children 6 months to 5 years after 24 weeks of treatment with MK0476. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MK0476 will be safe and well-tolerated in children 6 months to 5 years after 24 weeks of treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 2100
Study Start Date: November 2007
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Arm 1: drug
Drug: montelukast sodium
Patients >6 mos to <2 yrs: 4mg packet of oral granules (OG) qd; Patients >2 yrs to <64 mos: 4mg chewable tablet for a 24-wk treatment period.
Other Names:
  • MK0476
  • Singulair®
Placebo Comparator: 2
Arm 2: Pbo comparator
Drug: Comparator: placebo (unspecified)
Patients >6 mos to <2 yrs: 4mg packet of oral granules (OG) Pbo qd; Patients >2 yrs to <64 mos: 4mg chewable tablet Pbo for a 24-wk treatment period.

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is between 6 months and 5 years, 4 months of age
  • Patient has been diagnosed with asthma by a doctor
  • Patient has had at least 3 episodes of asthma symptoms within the last 6 months

Exclusion Criteria:

  • Patient has active or chronic breathing disease, other than asthma
  • Patient required insertion of a breathing tube for asthma
  • Patient had major surgery within the last 4 weeks
  • Patient is currently in the hospital
  • Patient is allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540839

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

Additional Information:
No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00540839     History of Changes
Other Study ID Numbers: 2007_583, MK0476-303
Study First Received: October 4, 2007
Last Updated: October 6, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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 April 15, 2014