Montelukast Post-Marketing Comparative Study With Ketotifen

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00446056

First received: March 9, 2007

Last updated: NA

Last verified: March 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

March 9, 2007

Last Updated Date

March 9, 2007

Start Date ^ICMJE

September 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Improvement of morning peak expiratory flow over first 2 weeks

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Montelukast Post-Marketing Comparative Study With Ketotifen

Official Title ^ICMJE

Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: MK0476, montelukast sodium / Duration of Treatment: 4 Weeks
Drug: Comparator: ketotifen / Duration of Treatment: 4 Weeks

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

180

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 14 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00446056

Other Study ID Numbers ^ICMJE

2007_010

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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