Dextromethorphan Pediatric Acute Cough Study

NCT02651116 | Terminated Phase 4 Results

• 2 other identifiers: A6531002CHPA DXM
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 18

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.

Conditions

Cough

Keywords

cough, acute cough, pediatric, Dextromethorphan Hydrobromide, antitussive, ambulatory cough recording device

Outcome Measures

Primary Outcomes (1)

• Mean of Total Cough Counts: Over 24 Hours Post-First Dose on Day 1

  Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated cough counts.

  Over for 24 hours post-first dose on Day 1

Secondary Outcomes (5)

• Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1

  Between Dose 1 to Dose 2 on Day 1

• Mean of Total Cough Counts: Between Dose 2 on Day 1 to Dose 3 on Day 2

  Between Dose 2 on Day 1 to Dose 3 on Day 2 (second dose of Day 1 to first dose of Day 2)

• Mean of Total Cough Counts: Between Dose 3 to Dose 4 on Day 2

  Between Dose 3 to Dose 4 on Day 2 (between first and second dose of Day 2)

• Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1, and Between Dose 3 to Dose 4 on Day 2

  Duration between Dose 1 to Dose 2 on Day 1 (between first and second dose of Day 1) plus duration between Dose 3 to Dose 4 on Day 2 (between first and second dose of Day 2)

• Mean of Total Cough Time Accumulated Over a 24-Hour Period Post-First Dose on Day 1

  Over for 24 hours post-first dose on Day 1

Other Outcomes (7)

• Change From Baseline in Morning Cough Frequency Assessed in Morning at Day 2, 3, and 4

  Baseline (morning screening visit on Day 1); Within 30 minutes of waking, before morning dose on Days 2, 3, and 4

• Change From Baseline in Morning Cough Severity Assessed in Morning at Day 2, 3, and 4

  Baseline (morning screening visit on Day 1); Within 30 minutes of waking, before morning dose on Days 2, 3, and 4

• Change From Baseline in Impact of Cough on Sleep Assessed in Morning at Day 2, 3, and 4

  Baseline (morning screening visit on Day 1); Within 30 minutes of waking, before morning dose on Days 2, 3, and 4

Study Arms (2)

Dextromethorphan Hydrobromide

EXPERIMENTAL

15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide

Drug: Dextromethorphan Hydrobromide; Device: Cough recording device

Placebo

PLACEBO COMPARATOR

10 mL of Placebo

Drug: Placebo; Device: Cough recording device

Interventions

Dextromethorphan Hydrobromide DRUG

15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide

Also known as: DXM

Dextromethorphan Hydrobromide

Placebo DRUG

10 mL Placebo

Placebo

Cough recording device DEVICE

FDA approved device validated for use in adults and children

Also known as: VitaloJAK

Dextromethorphan Hydrobromide; Placebo

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Clinical Associates of Orlando LLC

Orlando, Florida, 32806, United States

Location

Elite Clinical Trials LLLP

Blackfoot, Idaho, 83221, United States

Location

Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

Location

All Children Pediatrics

Louisville, Kentucky, 40243, United States

Location

Bluegrass Clinical Research, Inc

Louisville, Kentucky, 40291, United States

Location

MedPharmics, LLC

Metairie, Louisiana, 70006, United States

Location

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68504, United States

Location

Meridian Clinical Research LLC

Omaha, Nebraska, 68134, United States

Location

Rapid Medical Research, Inc

Cleveland, Ohio, 44122, United States

Location

Coastal Pediatric Associates

Charleston, South Carolina, 29414, United States

Location

Coastal Pediatric Associates

Mt. Pleasant, South Carolina, 29464, United States

Location

Carolina Ear, Nose & Throat Clinic/CENTRI Inc.

Orangeburg, South Carolina, 29118, United States

Location

Meridian Clinical Research, LLC

Dakota Dunes, South Dakota, 57049, United States

Location

Texas Health Care, PLLC

Fort Worth, Texas, 76104, United States

Location

Ventavia Research Group, LLC

Fort Worth, Texas, 76104, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Cough

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 8, 2016
• Study Start: February 25, 2016
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: April 28, 2021
• Results First Posted: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

US (18)