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Montelukast Post-Marketing Comparative Study With Ketotifen

2014-08-27 03:39:43 | BioPortfolio

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.

Study Design

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

Conditions

Asthma

Intervention

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

Status

Completed

Source

Merck

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:39:43-0400

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Medical and Biotech [MESH] Definitions

A cycloheptathiophene blocker of histamine H1 receptors and release of inflammatory mediators. It has been proposed for the treatment of asthma, rhinitis, skin allergies, and anaphylaxis.

CHILDBIRTH at the end of a normal duration of PREGNANCY, between 37 to 40 weeks of gestation or about 280 days from the first day of the mother's last menstrual period.

The three approximately equal periods of a normal human PREGNANCY. Each trimester is about three months or 13 to 14 weeks in duration depending on the designation of the first day of gestation.

High temperature weather exceeding the average and of several weeks duration. Extreme heat is a dangerous situation that can bring on health emergencies in susceptible people.

Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.

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