Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)
|ClinicalTrials.gov Identifier: NCT00446056|
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : September 15, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: MK0476, montelukast sodium / Duration of Treatment: 4 Weeks Drug: Comparator: ketotifen / Duration of Treatment: 4 Weeks||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||188 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate|
|Actual Study Start Date :||September 25, 2003|
|Primary Completion Date :||June 16, 2004|
|Study Completion Date :||June 16, 2004|
- Improvement of morning peak expiratory flow over first 2 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446056
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|