Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)
Phase 4
Completed
- Conditions
- Asthma
- Registration Number
- NCT00446056
- Lead Sponsor
- Organon and Co
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Improvement of morning peak expiratory flow over first 2 weeks
- Secondary Outcome Measures
Name Time Method