Acute Cough Study In Children
| Status: | Terminated |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - 11 |
| Updated: | 10/14/2017 |
| Start Date: | December 2010 |
| End Date: | March 2011 |
A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Single-Dose, Pilot Study To Evaluate Efficacy Of Dextromethorphan Hydrobromide On Acute Cough In A Pediatric Population
15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the
number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.
number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.
In light of protocol changes required due to methodological and operational issues, including
background noise in cough recordings which could impact data interpretation, the study has
been terminated.
background noise in cough recordings which could impact data interpretation, the study has
been terminated.
Inclusion Criteria:
Male or female healthy children ages 6 to under 12 years who are symptomatic with a cough
due to a cold or acute URTI characterized by:
- Onset of cold/URTI symptoms occurring no more than 10 days prior to Visit 1;
- At least 5 coughs during the second 30-minute period of the 60-minute baseline period.
General good health, aside from a common cold, and has no contraindications to the study or
rescue medication
Exclusion Criteria:
- Acute, subchronic, or chronic cough due to any other condition other than a common
cold
History of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological,
hematological, autoimmune, psychiatric, metabolic, gastro-intestinal or endocrine disease
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