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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: MK0476, montelukast sodium / Duration of Treatment: 4 Weeks; Drug: Comparator: ketotifen / Duration of Treatment: 4 Weeks

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement of morning peak expiratory flow over first 2 weeks

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• 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 record dates

Study Major Dates

• Study Start (Actual): September 25, 2003
• Primary Completion (Actual): June 16, 2004
• Study Completion (Actual): June 16, 2004

Study Registration Dates

• First Submitted: March 9, 2007
• First Submitted That Met QC Criteria: March 9, 2007
• First Posted (Estimate): March 12, 2007

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Montelukast; Ketotifen
• Other Study ID Numbers: 0476-379; 2007_010

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis