Dextromethorphan Pediatric Acute Cough Study | NCT02651116

Obsolete or Duplicate NCT IDs

Not provided

ID	Type	Description	Link
CHPA DXM	Other Identifier	Alias Study Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dextromethorphan Hydrobromide	Drug	15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide	Dextromethorphan Hydrobromide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mean of Total Cough Counts: Between Dose 1 to Dose 2 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.

Other Outcomes

Measure	Description	Time Frame
Change From Baseline in Morning Cough Frequency Assessed in Morning at Day 2, 3, and 4	Participants on specified time points were asked to respond to the following question: "from when you woke up this morning until now, how much have you been coughing", on a 5-point scale: 0= not at all, 1= a tiny bit, 2= a little, 3= some and 4= a lot. Higher scores indicated higher frequency of cough in morning time.

Eligibility Module

Eligibility 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

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Avail Clinical Research, LLC		DeLand	Florida	32720	United States
Clinical Associates of Orlando LLC

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 milligram [mg] per 10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 18, 2018	Mar 3, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

The safety analysis set included all participants who received the study drug.

Arm/Group Information

ID	Title	Description
BG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
BG001	Placebo	Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG0008.3± 1.57 BG0018.0± 1.73 BG0028.2± 1.65

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00035 BG00132 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0017 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data.

Posted

Mean

Standard Deviation

cough counts

Over for 24 hours post-first dose on Day 1

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
OG001	Placebo	Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.

Units	Counts
Participants	OG00067 OG00161

Title

Denominators

Categories

Title	Measurements
	OG000457.1± 367.21(367.21 to ) OG001676.8± 814.33(814.33 to )

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Estimated rate ratio (ratio of rate of cough counts per 24 hours for DXM HBr to placebo), and corresponding 95% confidence interval (CI) for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.	Negative Binomial Regression		0.0449	P-Value less than or equal to (<=) 0.05 level was considered significantly better and P-Value lying between 0.05 less than (<) p<=0.1 level was considered marginally significantly better.	Rate Ratio	0.7899	Standard Error of the Mean	0.0929	2-Sided	95	0.6273	0.9947

Secondary

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

The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

cough counts

Between Dose 1 to Dose 2 on Day 1

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
OG001	Placebo

Secondary

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

Posted

Mean

Standard Deviation

cough counts

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

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
OG001

Secondary

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

Posted

Mean

Standard Deviation

cough counts

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

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
OG001

Secondary

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

Posted

Mean

Standard Deviation

cough counts

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)

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.

Secondary

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

Time (in seconds) accumulated over a 24-hour period when cough events occurred 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 total cough time accumulated.

The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data.

Posted

Mean

Standard Deviation

seconds

Over for 24 hours post-first dose on Day 1

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
OG001	Placebo

Other Pre-specified

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

Participants on specified time points were asked to respond to the following question: "from when you woke up this morning until now, how much have you been coughing", on a 5-point scale: 0= not at all, 1= a tiny bit, 2= a little, 3= some and 4= a lot. Higher scores indicated higher frequency of cough in morning time.

The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'number analyzed' signifies participants with available data for each specified category.

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
OG001	Placebo

Other Pre-specified

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

Participants on specified time points were asked to respond to the following question: "how bad is your cough this morning", on a 5-point scale: 0= no cough, 1= a tiny bit bad, 2= a little bad, 3= bad and 4= very bad. Higher scores indicated more severe cough in morning time.

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
OG001	Placebo

Other Pre-specified

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

Participants on specified time points were asked to respond to the following question: "last night in bed, how much did your cough keep you awake", on a 5-point scale: 0= not at all, 1= a tiny bit, 2= a little, 3= some and 4= a lot. Higher scores indicated worse impact of cough on sleep.

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
OG001	Placebo

Other Pre-specified

Change From Baseline in Afternoon Cough Frequency Assessed at Afternoon on Day 2, 3, and 4

Participants on specified time points were asked to respond to the following question: "how much have you been coughing this afternoon" on a 5-point scale: 0= not at all, 1= a tiny bit, 2= a little, 3= some and 4= a lot. Higher scores indicated higher frequency of cough in afternoon time.

Posted

Mean

Standard Deviation

units on a scale

Baseline (afternoon visit on Day 1 before first dose); Before the afternoon dose on Day 2, and 3; Anytime in afternoon of Day 4

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
OG001	Placebo

Other Pre-specified

Change From Baseline in Afternoon Cough Severity Assessed at Afternoon on Day 2, 3, and 4

Participants on specified time points were asked to respond to the following question: "how bad is your cough this afternoon" on a 5-point scale: 0= no cough, 1= a tiny bit bad, 2= a little bad, 3= bad and 4= very bad. Higher scores indicated more severe cough in afternoon time.

Posted

Mean

Standard Deviation

units on a scale

Baseline (afternoon visit on Day 1 before first dose); Before the afternoon dose on Day 2, and 3; Anytime in afternoon of Day 4

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
OG001	Placebo

Other Pre-specified

Change From Baseline in Child Global Question Assessed at Afternoon on Day 2, 3, and 4

Participants on specified time points were asked to respond to the following question: "how bad is your cold today", on a 5-point scale; 0= no cold, 1= a tiny bit bad, 2= a little bad, 3= bad, and 4= very bad. Higher scores indicated worse cold.

Posted

Mean

Standard Deviation

units on a scale

Baseline (afternoon visit on Day 1 before first dose); Before the afternoon dose on Day 2, and 3; Anytime in afternoon of Day 4

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.
OG001	Placebo

Other Pre-specified

Pediatric Global Assessment of Satisfaction With Study Medication: By Participant, and Caregiver

Participants at the end of the study were asked to respond to the following question: "How would you rate the study medication for taking away your cough?" on a 7-point scale: 0= excellent, 1= very good, 2= good, 3= fair, 4= poor, 5= very poor, and 6= terrible. Higher scores indicated poorer satisfaction with study medication. Within 20 minutes after participants completed the assessment parents/legally acceptable representative were asked to respond to the question: "How would you rate the study medication for taking away your child's cough?" on a 7-point scale: 0= excellent, 1= very good, 2= good, 3= fair, 4= poor, 5= very poor, and 6= terrible. Higher scores indicated poorer satisfaction with study medication.

Posted

Mean

Standard Deviation

units on a scale

For participants: at the end of the study on Day 4; For parents/legally acceptable representatives: within 20 minutes after participant completed assessment at the end of the study on Day 4

ID	Title	Description
OG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dextromethorphan Hydrobromide	Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	0	68	0	68	13	68
EG001	Placebo	Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.	0	63	0	63	16	63

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected68 at risk EG0011 affected63 at risk
Tympanic membrane hyperaemia	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected63 at risk
Lip dry	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Malaise	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected63 at risk
Bronchiolitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Influenza	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Otitis media	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0012 affected63 at risk
Otitis media acute	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Viral infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Headache	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected68 at risk EG0013 affected63 at risk
Dennie-Morgan fold	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected68 at risk EG0010 affected63 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected63 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected63 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected68 at risk EG0011 affected63 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Nasal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected63 at risk
Nasal turbinate abnormality	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected68 at risk EG0011 affected63 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected68 at risk EG0011 affected63 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected63 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected68 at risk EG0013 affected63 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected63 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected68 at risk EG0012 affected63 at risk

ID	Term
D003371	Cough

ID	Term
D003915	Dextromethorphan

Ancestor Terms

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D006572	Heterocyclic Compounds, Bridged-Ring
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D010616	Phenanthrenes
D011084	Polycyclic Aromatic Hydrocarbons
D011083	Polycyclic Compounds

Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms