Acute Cough Study In Children

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Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dextromethorphan

Placebo

About this trial

This is an interventional treatment trial for Common Cold focused on measuring randomized, parallel, double-blind, placebo-controlled, cough, efficacy, safety, dextromethorphan

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female healthy children ages 6 to under 12 years who are symptomatic with a cough due to a cold or acute URTI characterized by:

Onset of cold/URTI symptoms occurring no more than 10 days prior to Visit 1;
At least 5 coughs during the second 30-minute period of the 60-minute baseline period.

General good health, aside from a common cold, and has no contraindications to the study or rescue medication

Exclusion Criteria:

Acute, subchronic, or chronic cough due to any other condition other than a common cold

History of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, hematological, autoimmune, psychiatric, metabolic, gastro-intestinal or endocrine disease

Sites / Locations

DMI Research
Concentrics Center for Research
Cyn3rgy Research
Clinical Research Associates Incorporated

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Total Cough Count

Total cough count was done by trained assessors using continuous digital video and audio recordings.

Secondary Outcome Measures

Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period

Perceived verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline over the 6-hour post-dosing period calculated as the average of change from baseline [that is (i.e.) baseline value minus the post baseline value] measurements of Hour 1 to Hour 6, thus the change from baseline ranged from -4 to 4; higher score indicated a better improvement.

Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6

Verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline values were derived by subtracting each post baseline value from the baseline value, and ranged from -4 to 4; higher score indicated a better improvement.

Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period

Perceived numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = did not cough at all and 10 = cough a lot. The change from baseline for the 6-hour post-dosing period was calculated as the average of change from baseline (i.e. baseline value minus the post baseline value) measurements of Hour 1 to Hour 6, thus the change from baseline values ranged from -10 to 10; higher score indicated a better improvement.

Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6

Numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", wherein 0 = did not cough at all and 10 = cough a lot. The change from baseline was derived by subtracting the post baseline value from the baseline value and ranged from -10 to 10; higher score indicated a better improvement.

Participants' Global Assessment of Cough: Cough Severity

Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question " How much have you coughed in the past 6 hours?" where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot.

Participants' Global Assessment of Cough: Relief From Cough

Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question "From when you woke up this morning until now, how much better is your cough?" where 0 = not at all better, 1 = a tiny bit better, 2 = a little better, 3 = better and 4 = a lot better.

Full Information

NCT ID

NCT01257542

First Posted

December 7, 2010

Last Updated

August 21, 2012

Sponsor

Pfizer

Collaborators

AccuDial Pharmaceutical, Inc., Boehringer Ingelheim, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc., Novartis, Perrigo Company, Procter and Gamble, Reckitt Benckiser LLC

1. Study Identification

Unique Protocol Identification Number

NCT01257542

Brief Title

Acute Cough Study In Children

Official Title

A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Single-Dose, Pilot Study To Evaluate Efficacy Of Dextromethorphan Hydrobromide On Acute Cough In A Pediatric Population

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

December 2010 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

AccuDial Pharmaceutical, Inc., Boehringer Ingelheim, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc., Novartis, Perrigo Company, Procter and Gamble, Reckitt Benckiser LLC

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.

Detailed Description

In light of protocol changes required due to methodological and operational issues, including background noise in cough recordings which could impact data interpretation, the study has been terminated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Common Cold, Infections, Upper Respiratory Tract

Keywords

randomized, parallel, double-blind, placebo-controlled, cough, efficacy, safety, dextromethorphan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Dextromethorphan

Intervention Description

A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

A single 10 mL dose of matching placebo syrup

Primary Outcome Measure Information:

Title

Total Cough Count

Description

Total cough count was done by trained assessors using continuous digital video and audio recordings.

Time Frame

Up to 6 hours post-dose

Secondary Outcome Measure Information:

Title

Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period

Description

Perceived verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline over the 6-hour post-dosing period calculated as the average of change from baseline [that is (i.e.) baseline value minus the post baseline value] measurements of Hour 1 to Hour 6, thus the change from baseline ranged from -4 to 4; higher score indicated a better improvement.

Time Frame

Baseline, 1, 2, 3, 4, 5, 6 hours post-dose

Title

Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6

Description

Verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline values were derived by subtracting each post baseline value from the baseline value, and ranged from -4 to 4; higher score indicated a better improvement.

Time Frame

Baseline, 1, 2, 3, 4, 5, 6 hours

Title

Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period

Description

Perceived numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = did not cough at all and 10 = cough a lot. The change from baseline for the 6-hour post-dosing period was calculated as the average of change from baseline (i.e. baseline value minus the post baseline value) measurements of Hour 1 to Hour 6, thus the change from baseline values ranged from -10 to 10; higher score indicated a better improvement.

Time Frame

Baseline, 1, 2, 3, 4, 5, 6 hour post-dose

Title

Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6

Description

Numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", wherein 0 = did not cough at all and 10 = cough a lot. The change from baseline was derived by subtracting the post baseline value from the baseline value and ranged from -10 to 10; higher score indicated a better improvement.

Time Frame

Baseline, 1, 2, 3, 4, 5, 6 hours

Title

Participants' Global Assessment of Cough: Cough Severity

Description

Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question " How much have you coughed in the past 6 hours?" where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot.

Time Frame

Within 5 minutes after Hour 6

Title

Participants' Global Assessment of Cough: Relief From Cough

Description

Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question "From when you woke up this morning until now, how much better is your cough?" where 0 = not at all better, 1 = a tiny bit better, 2 = a little better, 3 = better and 4 = a lot better.

Time Frame

Within 5 minutes after Hour 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Male or female healthy children ages 6 to under 12 years who are symptomatic with a cough due to a cold or acute URTI characterized by: Onset of cold/URTI symptoms occurring no more than 10 days prior to Visit 1; At least 5 coughs during the second 30-minute period of the 60-minute baseline period. General good health, aside from a common cold, and has no contraindications to the study or rescue medication Exclusion Criteria: Acute, subchronic, or chronic cough due to any other condition other than a common cold History of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, hematological, autoimmune, psychiatric, metabolic, gastro-intestinal or endocrine disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

DMI Research

City

Pinellas

State/Province

Florida

ZIP/Postal Code

33782-4533

Country

United States

Facility Name

Concentrics Center for Research

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46240

Country

United States

Facility Name

Cyn3rgy Research

City

Gresham

State/Province

Oregon

ZIP/Postal Code

97030

Country

United States

Facility Name

Clinical Research Associates Incorporated

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6531001&StudyName=Acute%20Cough%20Study%20In%20Children

Description

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

Common Cold, Infections, Upper Respiratory Tract

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial