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

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.

Timeline

Start

2003-09-25

Primary completion

2004-06-16

Completion

2004-06-16

Publications

• Results Sankei N, Kenshi F, Susumu F, Shigemi Y. Cysteinyl leukotriene receptor 1 antagonist; monterukast on childhood bronchial asthma in multicenter comparative double-blind study (Phase IV) with ketotifen fumarate. J Clin Therapeut Med. 2005;21(6):605-636

Drugs

Indications