Acute Cough Study In Children (NCT01257542) | Clinical Trial Compass
TerminatedPhase 4
Acute Cough Study In Children
Stopped: See termination reason in detailed description.
United States140 participantsStarted 2010-12
Plain-language summary
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.
Who can participate
Age range6 Years – 11 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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