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Acute Cough Study In Children

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
DMI Research
Pinellas, Florida, 33782-4533 United States
Contact
1-800-718-1021
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

NCT01257542
Pfizer
Terminated
Acute Cough Study In Children

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Acute Cough Study In Children
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
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Common Cold
  • Infections, Upper Respiratory Tract
  • 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
  • Experimental: Active
    Intervention: Drug: Dextromethorphan
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
140
March 2011
March 2011   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
6 Years to 11 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01257542
A6531001
RB-10-12
No
Not Provided
Not Provided
Pfizer
Pfizer
  • AccuDial Pharmaceutical
  • Boehringer Ingelheim
  • McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
  • Novartis
  • Perrigo Company
  • Procter and Gamble
  • Reckitt Benckiser LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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