The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen, used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over first 2 weeks in patients with pediatric bronchial asthma aged 6 to < 15. The effect of body weight on the efficacy and safety of montelukast will also be evaluated in this study...
Date First Received: March 9, 2007
Last Updated: March 9, 2007
Verified by: Merck, March 2007
Clinical Trial Phase: Phase 4 | Start Date: September 2003
Overall Status: Completed
Estimated Enrollment: 180
Brief Summary
Official Title: “Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate”
Condition Keyword(s):
The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen, used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over first 2 weeks in patients with pediatric bronchial asthma aged 6 to < 15.
The effect of body weight on the efficacy and safety of montelukast will also be evaluated in this study.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0476, montelukast sodium / Duration of Treatment: 4 Weeks
- Drug: Comparator: ketotifen / Duration of Treatment: 4 Weeks
Outcome Measures for this Clinical Trial
Primary Measures
- Improvement of morning peak expiratory flow over first 2 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Intermittent asthma, mild persistent asthma, moderate persistent asthma, or severe persistent asthma patients with 2 or more mild or moderate attacks at baseline
Exclusion Criteria:
- Patient using anti-asthma treatment or therapy including corticosteroids or oral anti-allergic drugs
- Patient with complications that will impair the judgment of efficacy of this drug
- Patient with convulsive disorders such as epilepsy or such a history
- Patient with liver disease, renal impairment, heart disease or such other complication
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Years
Maximum Age for this Clinical Trial: 14 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on January 08, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00446056
Study ID Number: 2007_010
ClinicalTrials.gov Identifier: NCT00446056
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
