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Acute Cough Study In Children

NCT01257542 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2012-09-20

Study results available
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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.

Conditions

  • Common Cold
  • Infections, Upper Respiratory Tract

Interventions

DRUG

Dextromethorphan

A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg)

DRUG

Placebo

A single 10 mL dose of matching placebo syrup

Sponsors & Collaborators

  • AccuDial Pharmaceutical, Inc.

    collaborator OTHER

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • Perrigo Company

    collaborator INDUSTRY

  • Procter and Gamble

    collaborator INDUSTRY

  • Reckitt Benckiser LLC

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01257542 on ClinicalTrials.gov