A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: montelukast (Drug); placebo (unspecified) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to
5 Years.
Clinical Details
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: asthma episodes in 2 - 5 year old children
Secondary outcome: the number of treatments and duration of asthma episodes
Eligibility
Minimum age: 2 Years.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or Female between and including the ages of 2 and 5 years
- Patient was treated with steroids for an asthma episode in the last 3 months
- Patient was admitted to the hospital or emergency room in the last 3 months
- Patient is able to chew a tablet
Exclusion Criteria:
- Patient has been in a research study in the past 4 weeks
- Patient has visited the emergency room for an asthma episode in the past week
- Patients has a history of stomach, heart, liver, nerve, kidney or blood disease
Locations and Contacts
Additional Information
MedWatch - FDA maintained medical product safety Information PhRMA Clinical Study Results Database - web-based repository for clinical study results Merck: Patient & Caregiver U.S. Product Web Site
Last updated: June 18, 2008
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