Acute Cough Study In Children
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
140 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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