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Dextromethorphan Pediatric Acute Cough Study

Last updated on September 10, 2019
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cough
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.
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  •  Generally healthy male or female children/adolescents ages 6 to 11 years. - Subject has an acute cough and other symptoms consistent with a common cold/acute upper respiratory tract infection (URTI) diagnosis as deemed by the investigator.

  • The onset of symptoms must be no more than 3 days prior to Visit 1, as determined by the subject or parent/legally acceptable representative.
  • Qualifying responses on study questionnaires.
  • Parent/legally acceptable representative, and subject agrees the subject will not use any other cough or cold treatments during the study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Fever greater than 102ºF oral temperature at the time of screening.

- Diabetes or hypoglycemic disorders.

- Known or suspected allergies to the investigational product or acetaminophen (APAP).

- History of taking a medication that is sedating within the past 24 hours prior to
screening (eg sedatives, hypnotics, tranquilizers, anticonvulsants, benzodiazepines,
and clonidine).

- Subject has a sibling participating at the same time in this study.
Randomization Criteria:

- Subjects must wear cough counting device for two hours and then return to the study site to complete screening procedures.

- Subjects whose equipment failed or those who took off the device during this period will be excluded from further study participation.

- Subjects who do not return to the study site (before 3:30 pm) in time for the afternoon dose will be excluded from further study participation.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Liquid
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes only
Duration
The time commitment for participation in the study.
Follow up: Estimated 2 weeks
Screening: 1 days
Treatment: 4 days
Site Visits
Follow up: visits
Screening: 2 visits
Treatment: 2 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Keeping a diary
Physical examination
Questionnaire
Vital signs and measurements
NCT02651116
Pfizer
Recruiting
Dextromethorphan Pediatric Acute Cough Study

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Cough
NCT02651116
All Genders
6+
Years
Multiple Sites

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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