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

Sponsor:	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

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:

MedlinePlus related topics: Asthma

Drug Information available for: Ketotifen Ketotifen fumarate Montelukast sodium Montelukast

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ketotifen
Montelukast
Antipruritics
Dermatologic Agents
Therapeutic Uses

Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012