Montelukast Post-Marketing Comparative Study With Ketotifen - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00446056

Purpose

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 IV

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast Ketotifen Ketotifen fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate

Further study details as provided by Merck:

Primary Outcome Measures:

Improvement of morning peak expiratory flow over first 2 weeks

Estimated Enrollment:	180
Study Start Date:	September 2003

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446056

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2007_010
Study First Received:	March 9, 2007
Last Updated:	March 9, 2007
ClinicalTrials.gov Identifier:	NCT00446056
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Montelukast
Hypersensitivity
Lung Diseases, Obstructive
Ketotifen
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Histamine phosphate
Asthma
Leukotriene Antagonists
Histamine
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents

Histamine Agents
Anti-Allergic Agents
Pharmacologic Actions
Histamine Antagonists
Therapeutic Uses
Antipruritics
Histamine H1 Antagonists
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009