Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Merck |
---|---|
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00076973 |
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.
Condition | Intervention | Phase |
---|---|---|
Bronchiolitis |
Drug: montelukast sodium Drug: Comparator: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 1125 |
Study Start Date: | July 2003 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 3 Months to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2004_098, Formerly 0112BRS, MK0476-272 |
Study First Received: | February 6, 2004 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00076973 History of Changes |
Health Authority: | United States: Food and Drug Administration |
RSV Bronchiolitis |
Bronchial Diseases Hormone Antagonists Bronchiolitis Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Hormones Leukotriene Antagonists Virus Diseases |
Montelukast Signs and Symptoms Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Signs and Symptoms, Respiratory Bronchitis |
Respiratory System Agents Bronchial Diseases Bronchiolitis Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Pharmacologic Actions Leukotriene Antagonists |
Montelukast Signs and Symptoms Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Lung Diseases Signs and Symptoms, Respiratory Bronchitis |