Acute Cough Study In Children

NCT01257542

Last updated date
Study Location
DMI Research
Pinellas, Florida, 33782-4533, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Common Cold, Upper Respiratory Tract Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-11 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Common Cold, Upper Respiratory Tract InfectionsAcute Cough Study In Children
NCT01257542
  1. Pinellas, Florida
  2. Indianapolis, Indiana
  3. Gresham, Oregon
  4. Nashville, Tennessee
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Acute Cough Study In Children
Official Title  ICMJE A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Single-Dose, Pilot Study To Evaluate Efficacy Of Dextromethorphan Hydrobromide On Acute Cough In A Pediatric Population
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Common Cold
  • Infections, Upper Respiratory Tract
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Active
    Intervention: Drug: Dextromethorphan
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 28, 2012)
140
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2010)
240
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01257542
Other Study ID Numbers  ICMJE A6531001
RB-10-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • AccuDial Pharmaceutical, Inc.
  • Boehringer Ingelheim
  • McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
  • Novartis
  • Perrigo Company
  • Procter and Gamble
  • Reckitt Benckiser LLC
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP