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

NCT00446056 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2024-08-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

MK0476, montelukast sodium / Duration of Treatment: 4 Weeks

DRUG

Comparator: ketotifen / Duration of Treatment: 4 Weeks

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-25
Primary Completion
2004-06-16
Completion
2004-06-16

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00446056 on ClinicalTrials.gov