Status:
TERMINATED
Acute Cough Study In Children
Lead Sponsor:
Pfizer
Collaborating Sponsors:
AccuDial Pharmaceutical, Inc.
Boehringer Ingelheim
Conditions:
Common Cold
Infections, Upper Respiratory Tract
Eligibility:
All Genders
6-11 years
Phase:
PHASE4
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01257542
Start Date
December 1 2010
End Date
March 1 2011
Last Update
September 20 2012
Active Locations (4)
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1
DMI Research
Pinellas Park, Florida, United States, 33782-4533
2
Concentrics Center for Research
Indianapolis, Indiana, United States, 46240
3
Cyn3rgy Research
Gresham, Oregon, United States, 97030
4
Clinical Research Associates Incorporated
Nashville, Tennessee, United States, 37203