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This study has been withdrawn prior to enrollment.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

October 4, 2007
October 6, 2009
November 2007
March 2008   (final data collection date for primary outcome measure)
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 ]
Improvement of chronic (long-lasting) asthma in children 6 months to 5 years after 24 weeks of treatment with MK0476. [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00540839 on ClinicalTrials.gov Archive Site
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 ]
MK0476 will be safe and well-tolerated in children 6 months to 5 years after 24 weeks of treatment. [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
A Study of MK0476 Compared With Placebo in Pediatric Patients With Chronic Asthma
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma, Bronchial
  • 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®
  • 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.
  • Experimental: 1
    Arm 1: drug
    Intervention: Drug: montelukast sodium
  • Placebo Comparator: 2
    Arm 2: Pbo comparator
    Intervention: Drug: Comparator: placebo (unspecified)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
2100
Not Provided
March 2008   (final data collection date for primary outcome measure)

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
Both
6 Months to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00540839
2007_583, MK0476-303
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP