Acute Cough Study In Children

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Common Cold, Infections, Upper Respiratory Tract

In brief

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.

Key facts

Study ID

NCT01257542

Run by

Pfizer

People needed

140

Starts

2010-12-01

Expected to finish

2011-03-01

Last updated by the study team

2012-09-20

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• DMI Research — Pinellas Park, Florida, United States
• Concentrics Center for Research — Indianapolis, Indiana, United States
• Cyn3rgy Research — Gresham, Oregon, United States
• Clinical Research Associates Incorporated — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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