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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: March 9, 2007
Last updated: December 16, 2015
Last verified: December 2015

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 Intervention Phase
Drug: MK0476, montelukast sodium / Duration of Treatment: 4 Weeks
Drug: Comparator: ketotifen / Duration of Treatment: 4 Weeks
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Improvement of morning peak expiratory flow over first 2 weeks

Enrollment: 188
Study Start Date: September 2003
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00446056

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00446056     History of Changes
Other Study ID Numbers: 0476-379  2007_010 
Study First Received: March 9, 2007
Last Updated: December 16, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Anti-Allergic Agents
Anti-Asthmatic Agents
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Dermatologic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 26, 2016