Acute Cough Study In Children

Common Cold Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01257542
• Other study ID #: A6531001
• Secondary ID: RB-10-12
• Status: Terminated
• Phase: Phase 4
• First received: December 7, 2010
• Last updated: August 21, 2012
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: August 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Common Cold
• Infections, Upper Respiratory Tract
• Respiratory Tract Infections

Intervention

Drug:
• Dextromethorphan
A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg)
• Placebo
A single 10 mL dose of matching placebo syrup

Locations

Country	Name	City	State
United States	Cyn3rgy Research	Gresham	Oregon
United States	Concentrics Center for Research	Indianapolis	Indiana
United States	Clinical Research Associates Incorporated	Nashville	Tennessee
United States	DMI Research	Pinellas	Florida

Sponsors (8)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Cough Count	Total cough count was done by trained assessors using continuous digital video and audio recordings.	Up to 6 hours post-dose
Secondary	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.	Baseline, 1, 2, 3, 4, 5, 6 hours post-dose
Secondary	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.	Baseline, 1, 2, 3, 4, 5, 6 hours
Secondary	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.	Baseline, 1, 2, 3, 4, 5, 6 hour post-dose
Secondary	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.	Baseline, 1, 2, 3, 4, 5, 6 hours
Secondary	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.	Within 5 minutes after Hour 6
Secondary	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.	Within 5 minutes after Hour 6

External Links

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