A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years - Tabular View

Tracking Information

First Received Date ^ICMJE

June 17, 2008

Last Updated Date

September 23, 2009

Start Date ^ICMJE

Primary Completion Date

December 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

asthma episodes in 2 - 5 year old children [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00700661 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

the number of treatments and duration of asthma episodes [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years

Official Title ^ICMJE

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

Brief Summary

A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: montelukast
Drug: placebo (unspecified)

Study Arms / Comparison Groups

Experimental: Drug
Placebo Comparator: Pbo

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

Primary Completion Date

December 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

2 Years to 5 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00700661

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2007_572, MK0476-907

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP