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Dextromethorphan Pediatric Acute Cough Study (CHPA DXM)

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ClinicalTrials.gov Identifier: NCT02651116
Recruitment Status : Terminated (The study was prematurely discontinued due to slow enrollment during the 2019/2020 cold season. No safety or efficacy concerns led to the decision to terminate)
First Posted : January 8, 2016
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cough Drug: Dextromethorphan Hydrobromide Drug: Placebo Device: Cough recording device Phase 4

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP PILOT STUDY TO EVALUATE THE EFFICACY OF DEXTROMETHORPHAN HYDROBROMIDE ON ACUTE COUGH IN A PEDIATRIC POPULATION
Actual Study Start Date : February 25, 2016
Actual Primary Completion Date : March 19, 2020
Actual Study Completion Date : March 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: Dextromethorphan Hydrobromide
15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide
Drug: Dextromethorphan Hydrobromide
15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide
Other Name: DXM

Device: Cough recording device
FDA approved device validated for use in adults and children
Other Name: VitaloJAK

Placebo Comparator: Placebo
10 mL of Placebo
Drug: Placebo
10 mL Placebo

Device: Cough recording device
FDA approved device validated for use in adults and children
Other Name: VitaloJAK




Primary Outcome Measures :
  1. total cough count for 24 hours [ Time Frame: Day 1 ]
    total cough count collected by the cough recording device in an ambulatory setting over a 24-hour interval post-first dose on Day 1


Secondary Outcome Measures :
  1. total cough count for first dosing interval [ Time Frame: Day1 to Day 2 ]
    total cough count collected by the cough recording device during the first dosing interval (Dose 1 to Dose 2) on Day 1

  2. total cough count overnight [ Time Frame: Day1 to Day 2 ]
    total cough count collected by the cough recording device over the dosing interval from evening dose (Dose 2) on Day 1 to morning dose (Dose 3) on Day 2 (i.e. night time cough count)

  3. total cough count in the third dosing interval (Day 2) [ Time Frame: Day 2 ]
    total cough count collected by the cough recording device over the first dosing interval on Day 2 (interval between morning dose and afternoon dose on Day 2, ie, Dose 3 to Dose 4)

  4. change from screening in Patient Reported Outcomes (PRO) response [ Time Frame: Day 1 to 4 ]
    change from screening evaluation (assessed in the morning) in morning cough frequency ("from when you woke up this morning until now, how much have you been coughing"), cough severity ("how bad is your cough this morning"), and impact on sleep ("last night in bed, how much did your cough keep you awake"), assessed by subject

  5. change from baseline in PRO responses [ Time Frame: Day 1 to 4 ]
    change from baseline evaluation (assessed at afternoon) in afternoon cough frequency ("how much have you been coughing this afternoon") and severity ("how bad is your cough this afternoon") in the afternoon of Days 2-4, assessed by subject

  6. change from baseline in PRO responses [ Time Frame: Day 1 to Day 4 ]
    change from baseline evaluation (assessed at afternoon) in daily assessment of the cold in the Child Global Question ("how bad is your cold today"), assessed by subject

  7. subject and caregiver satisfaction with study medication [ Time Frame: Day 1 to Day 4 ]
    subject and parent/legally acceptable representative global assessment of satisfaction with study medication at the end of the study

  8. total cough count for first dosing interval (Day 1) and third dosing interval (Day 2) [ Time Frame: Day 1 to Day 2 ]
    total cough count collected by the cough recording device over the first dosing interval on Day 1 (Dose 1 to Dose 2) and the first dosing interval on Day 2 (Dose 3 to Dose 4). These 2 dose intervals approximately represent the daytime cough count.

  9. time accumulated over a 24-hour period when cough events occurred [ Time Frame: Day 1 to Day 2 ]
    time accumulated over a 24-hour period when cough events occurred



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651116


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02651116    
Other Study ID Numbers: A6531002
CHPA DXM ( Other Identifier: Alias Study Number )
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Keywords provided by Pfizer:
cough, acute cough, pediatric, Dextromethorphan Hydrobromide, antitussive, ambulatory cough recording device
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs