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: September 25, 2014
Last verified: September 2014

March 9, 2007
September 25, 2014
September 2003
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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.

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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
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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
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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.
September 2014

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