Completed
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
What is being tested
Data Collection
Who is being recruted
Bronchial Diseases+5
+ Bronchiolitis
+ Bronchitis
From 3 to 24 Months
+2 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: August 2003
Summary
Principal SponsorOrganon and Co
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2003
Actual date on which the first participant was enrolled.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.
Official TitleA 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
Principal SponsorOrganon and Co
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
1125 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 3 to 24 Months
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bronchial DiseasesBronchiolitisBronchitisInfectionsLung DiseasesLung Diseases, ObstructiveRespiratory Tract DiseasesRespiratory Tract Infections
Criteria
1 inclusion criteria required to participate
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.
1 exclusion criteria prevent from participating
Asthma or other wheezing disorder. The Primary Investigator will evaluate whether there are other reasons why a child may not participate.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers