An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 6, 2004

Last Updated Date

September 8, 2008

Start Date ^†

July 2003

Current Primary Outcome Measures ^†

Percentage of Symptom-Free Days

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00076973 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Percentage of Patients with Exacerbations and Percentage of Bronchiolitis-Free Days

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis

Official Title ^†

A Randomized, 2-Period, Multicenter, Dble-Blind, Parallel-Group Study Comparing Effects of 2 Doses of MK0476 and Placebo in the Tx of Respiratory Symptoms Associated w/ Respiratory Syncytial Virus-Induced Bronchiolitis in Children 3 to 24 Mths

Brief Summary

The purpose of this study is to look at whether an investigational drug can treat the breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Bronchiolitis

Intervention ^†

Drug: montelukast sodium
Drug: Comparator: placebo

Study Arms / Comparison Groups

Publications *

Bisgaard H, Flores-Nunez A, Goh A, Azimi P, Halkas A, Malice MP, Marchal JL, Dass SB, Reiss TF, Knorr BA. Study Of Montelukast for theTreatment of Respiratory Symptoms of Post-RSV-Bronchiolitis in Children. Am J Respir Crit Care Med. 2008 Jun 26; [Epub ahead of print]

* 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 ^†

Completed

Enrollment ^†

1125

Completion Date

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Hospitalized or in an urgent/emergent-care setting at least 24 hours for a first or second episode of RSV-induced bronchiolitis. Approximately twenty percent of patients will be allowed in the study with a stay of less than 24 hours but need to meet a minimum predefined Respiratory Severity Score as required by the study.

Exclusion Criteria:

Asthma or other wheezing disorder. The Primary Investigator will evaluate whether there are other reasons why a child may not participate.

Gender

Both

Ages

3 Months to 24 Months

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00076973

Responsible Party

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

Secondary IDs ^††

Formerly 0112BRS, MK0476-272

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.