A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years
A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years...
Brief Summary
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”
A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: December 2002
Intervention(s) in this Clinical Trial
- Drug: montelukast
- One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks
- Drug: placebo (unspecified)
- Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Drug
- Placebo Comparator: 2
- Pbo
Outcome Measures for this Clinical Trial
Primary Measures
- asthma episodes in 2 - 5 year old children
- Time Frame: at 12 months
Safety Issue?: No
- Time Frame: at 12 months
Secondary Measures
- the number of treatments and duration of asthma episodes
- Time Frame: at 12 months
Safety Issue?: No
- Time Frame: at 12 months
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 2 Years
Maximum Age for this Clinical Trial: 5 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Bisgaard H, Zielen S, Garcia-Garcia ML, Johnston SL, Gilles L, Menten J, Tozzi CA, Polos P. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005 Feb 15;171(4):315-22. Epub 2004 Nov 12.
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00700661
Study ID Number: 2007_572
ClinicalTrials.gov Identifier: NCT00700661
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
MedWatch - FDA maintained medical product safety Information
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00700661
