Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)

• Status: Completed
• Trial end date: 2004-06-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ketotifen; Montelukast

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