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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

Primary Measures

• asthma episodes in 2 - 5 year old children
  • Time Frame: at 12 months
    Safety Issue?: No

Secondary Measures

• the number of treatments and duration of asthma episodes
  • Time Frame: at 12 months
    Safety Issue?: No

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

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on September 05, 2008

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

PhRMA Clinical Study Results Database - web-based repository for clinical study results

Merck: Patient & Caregiver U.S. Product Web Site