Acute Cough Study In Children

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborators: AccuDial Pharmaceutical; AccuDial Pharmaceutical, Inc.; Boehringer Ingelheim; McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.; Novartis; Perrigo Company; Procter and Gamble; Reckitt Benckiser LLC
• Treatments: Dextromethorphan

Criteria

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