Montelukast Post-Marketing Comparative Study With Ketotifen

Official Title: “Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate”

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.

Intervention(s) in this Clinical Trial

• Drug: MK0476, montelukast sodium / Duration of Treatment: 4 Weeks
• Drug: Comparator: ketotifen / Duration of Treatment: 4 Weeks

Primary Measures

• Improvement of morning peak expiratory flow over first 2 weeks

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

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 09, 2012

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