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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00446056
• Collaborator: (none)
• Enrollment: 188
• Actual Duration (Months): 8.7

Study Details

Study Description

Brief Summary

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 188 participants
• 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
• Actual Study Start Date: Sep 25, 2003
• Actual Primary Completion Date: Jun 16, 2004
• Actual Study Completion Date: Jun 16, 2004

Outcome Measures

Primary Outcome Measures

1. Improvement of morning peak expiratory flow over first 2 weeks []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 14 Years
• 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

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00446056
• Other Study ID Numbers: 0476-379; 2007_010
• First Posted: Mar 12, 2007
• Last Update Posted: Feb 2, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Asthma; Ketotifen; Montelukast

Study Results

No Results Posted as of Feb 2, 2022