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

Organon

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

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

Drug: Comparator: ketotifen / Duration of Treatment: 4 Weeks

Study type

Interventional

Funder types

Industry

Identifiers

NCT00446056

0476-379

2007_010

Details and patient eligibility

About

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.

Enrollment

188 patients

Sex

All

Ages

6 to 14 years old

Volunteers

No Healthy Volunteers

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