ClinicalTrials.Veeva

Menu

An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis (0476-272)

Organon logo

Organon

Status and phase

Completed
Phase 3

Conditions

Bronchiolitis

Treatments

Drug: montelukast sodium
Drug: Comparator: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00076973
0476-272
Formerly 0112BRS
2004_098
MK0476-272

Details and patient eligibility

About

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.

Enrollment

1,125 patients

Sex

All

Ages

3 to 24 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems