A Study of MK0476 Compared With Placebo in Pediatric Patients With Chronic Asthma
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma, Bronchial
Intervention: montelukast sodium (Drug); Comparator: placebo (unspecified) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
A study to determine the effects of MK0476 on pediatric patient with chronic asthma compared
with placebo.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement of chronic (long-lasting) asthma in children 6 months to 5 years after 24 weeks of treatment with MK0476.
Secondary outcome: MK0476 will be safe and well-tolerated in children 6 months to 5 years after 24 weeks of treatment.
Eligibility
Minimum age: 6 Months.
Maximum age: 5 Years.
Gender(s): Both.
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
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Michel Cimon, Phone: 514-428-2605
Call for Information, South Jordan, Utah 84095, United States; Recruiting
Additional Information
MedWatch - FDA maintained medical product safety Information PhRMA Clinical Study Results Database - web-based repository for clinical study results Merck: Patient & Caregiver U.S. Product Web Site
Starting date: November 2007
Last updated: January 8, 2009
|
