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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00446056
First received: March 9, 2007
Last updated: December 16, 2014
Last verified: December 2014

March 9, 2007
December 16, 2014
September 2003
June 2004   (final data collection date for primary outcome measure)
Improvement of morning peak expiratory flow over first 2 weeks
Same as current
Complete list of historical versions of study NCT00446056 on ClinicalTrials.gov Archive Site
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Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
  • Drug: MK0476, montelukast sodium / Duration of Treatment: 4 Weeks
  • Drug: Comparator: ketotifen / Duration of Treatment: 4 Weeks
Not Provided
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
188
June 2004
June 2004   (final data collection date for primary outcome measure)

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
Both
6 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00446056
0476-379, 2007_010
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP