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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: September 14, 2017
Last verified: September 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 Intervention Phase
Asthma 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
Intervention Model: Parallel Assignment
Masking: Double
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
Actual Study Start Date: September 25, 2003
Study Completion Date: June 16, 2004
Primary Completion Date: June 16, 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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

Study Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00446056     History of Changes
Other Study ID Numbers: 0476-379
Study First Received: March 9, 2007
Last Updated: September 14, 2017

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Anti-Allergic Agents processed this record on September 21, 2017