Montelukast Post-Marketing Comparative Study With Ketotifen
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: MK0476, montelukast sodium / Duration of Treatment: 4 Weeks (Drug); Comparator: ketotifen / Duration of Treatment: 4 Weeks (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
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.
Clinical Details
Official title: Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement of morning peak expiratory flow over first 2 weeks
Eligibility
Minimum age: 6 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: September 2003
Last updated: March 9, 2007
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