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Acute Cough Study In Children | Clinical Trials | Clareo Health

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TERMINATEDPhase 4NCT01257542

Acute Cough Study In Children

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.

Lead sponsor: Pfizer•4 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Pfizer

Collaborators

AccuDial Pharmaceutical, Inc.
Boehringer Ingelheim
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Novartis
Perrigo Company
Procter and Gamble
Reckitt Benckiser LLC

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.

Age

6 - 11 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 20, 2012Terms

Trial snapshot

StatusTERMINATED

PhasePHASE4

Enrollment140

Start dateDec 2010

Last updatedSep 20, 2012

Condition

Common Cold Infections, Upper Respiratory Tract

Locations shown

DMI Research

Pinellas Park, Florida

Concentrics Center for Research

Indianapolis, Indiana

Cyn3rgy Research

Gresham, Oregon

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 20, 2012Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions