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Dextromethorphan Pediatric Acute Cough Study

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Avail Clinical Research, LLC
DeLand, Florida, 32720 United States
Contact
1-800-718-1021
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.
Show details
  •  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.
Show details

- 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.
Treatment: 4 days
Follow up: Estimated 2 weeks
Screening: 1 days
Site Visits
Treatment: 2 visits
Follow up: visits
Screening: 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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Dextromethorphan Pediatric Acute Cough Study
A Placebo-controlled, Double-blind, Randomized, Parallel Group Pilot Study To Evaluate The Efficacy Of Dextromethorphan Hydrobromide On Acute Cough In A Pediatric Population
This is a placebo-controlled, double-blind, randomized, parallel group pilot study in approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide (DXM) on acute cough in a pediatric population. Subjects will be otherwise healthy males and females aged 6-11 inclusive who are experiencing acute cough as a symptom of common cold or upper respiratory tract infection. Subjects must have had onset of symptoms within 3 days of screening and qualify based on physical exam and symptom questionnaire. Eligible subjects will be given a single-blind placebo, and fitted with a cough counting device for a 2 hour run-in period. Qualifying subjects will be stratified by age and then randomized to either DXM or placebo in a 1:1 ratio and fitted with the cough recording device for the first 24 hours of treatment. Subjects will receive approximately 9 doses of investigational product over the course of the 4 day study and will complete patient reported outcome questions before the morning and afternoon doses. Subjects will return to the study site on Day 2 to remove the cough recorder and on Day 4 (+ 2 days) to complete the final visit. A review of any reported adverse events will also be completed.
This is a placebo-controlled, double-blind, randomized, parallel group pilot study in approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide DXM) on acute cough in a pediatric population. Subjects will be otherwise healthy males and females aged 6-11 inclusive who are experiencing acute cough as a symptom of common cold or upper respiratory tract infection. Subjects must have had onset of symptoms within 3 days of screening and qualify based on physical exam and symptom questionnaire. Eligible subjects will be given a single-blind placebo, and fitted with a cough counting device for a 2 hour run-in period. Qualifying subjects will be stratified by age and then randomized to either DXM or placebo in a 1:1 ratio and fitted with the cough recording device for the first 24 hours of treatment. Subjects will receive approximately 9 doses of investigational product over the course of the 4 day study and will complete patient reported outcome questions before the morning and afternoon doses. Subjects will return to the study site on Day 2 to remove the cough recorder and Day 4 (+2 days) to complete the final visit. A review of any reported adverse events will also be completed. Validated Patient Reported Outcomes (PRO) used in the study include morning cough assessment, afternoon cough assessment, Child Global Question, and Child Cold Symptom Checklist
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Cough
  • Drug: Dextromethorphan Hydrobromide
    15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide
    Other Name: DXM
  • Drug: Placebo
    10 mL Placebo
  • Device: Cough recording device
    FDA approved device validated for use in adults and children
    Other Name: VitaloJAK
  • Experimental: Dextromethorphan Hydrobromide
    15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide
    Interventions:
    • Drug: Dextromethorphan Hydrobromide
    • Device: Cough recording device
  • Placebo Comparator: Placebo
    10 mL of Placebo
    Interventions:
    • Drug: Placebo
    • Device: Cough recording device
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
April 3, 2018
April 3, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Generally healthy male or female children/adolescents ages 6 to 11 years, inclusive.
  • 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 or qualified designee based on findings from medical history review, full physical examination and vital signs.
  • 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 response on the Child Cold Symptom Checklist.
  • Parent/legally acceptable representative, and subject agrees the subject will not use any other cough or cold treatments during the study.

Exclusion Criteria:

  • A subchronic, or chronic cough due to any condition other than an URTI or common cold as established by the investigator, nurse practitioner, or physician's assistant, in accordance with the American College of Chest Physicians' (ACCP) Guidelines for Diagnosis and Management of Cough. Special attention should be paid to highly prevalent conditions commonly presenting with cough such as asthma, rhinitis, or gastroesophageal reflux disease (GERD).
  • Symptoms of runny nose, stuffy nose, sore throat, or sneezing due to any condition other than URTI or common cold (eg, seasonal or perennial allergic rhinitis, sinusitis, strep throat, vasomotor rhinitis, etc.) as established by the investigator.
  • An acute cough that occurs with excessive phlegm (mucus) or is chronic such as occurs with smoking, asthma, bronchitis, allergies, or a gastroesophageal condition (eg, acid reflux and GERD) or history of such a cough.
  • Clinical features of a complication of the common cold during the physical examination at screening (eg, otitis media, sinusitis, or pneumonia) with or without the need for systematic antibiotics.
  • Pneumonia (active or with a symptom-free period of <30 days), asthma (active or with a symptom-free period of <1 year), or other significant pulmonary diseases.
  • Fever greater than 39ºC (102ºF oral temperature) at the time of screening if, in the judgment of the investigator, the individual is too ill to participate in the study or the fever is due to reasons other than URTI.
  • Signs of dehydration (as may be due to vomiting, diarrhea, or lack of fluid intake) during the physical examination at screening.
  • Diabetes or hypoglycemic disorders.
  • Known contraindications to the investigational product or acetaminophen (APAP).
  • Sitting blood pressure reading at or above the limits as documented in the protocol.
  • Obstructive sleep apnea caused by enlarged tonsils and adenoids, low muscle tone, or allergies.
  • History of known or suspected allergy or hypersensitivity to dextromethorphan (DXM) or APAP, or any of the non medicinal ingredients contained in the single-blind confection, double-blind investigational products, or APAP.
  • History of taking any of the specified prohibited medications or products within the corresponding washout periods prior to taking the first dose of investigational product.
  • 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 contemporaneously participating in this study.

Randomization Criteria:

  • Subjects must complete the 2 hour ambulatory cough counting baseline run-in recording period and must return to the study site for randomization at least 2 hours after the recording started.
  • Subjects whose equipment failed, preventing collection of cough count data for at least 2 hours during the Baseline Run-in Period, 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 not be randomized.
  • Qualifying response on Child Global Question
Sexes Eligible for Study: All
6 Years to 11 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT02651116
A6531002
CHPA DXM ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

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

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