Acute Cough Study In Children

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Collaborators:
AccuDial Pharmaceutical
Boehringer Ingelheim
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Novartis
Perrigo Company
Procter and Gamble
Reckitt Benckiser LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01257542
First received: December 7, 2010
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Common Cold
Infections, Upper Respiratory Tract
Drug: Dextromethorphan
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Total Cough Count [ Time Frame: Up to 6 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6 hour post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 5 minutes after Hour 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 5 minutes after Hour 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 140
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active 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 Comparator: Placebo Drug: Placebo
A single 10 mL dose of matching placebo syrup

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.

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257542

Locations
United States, Florida
DMI Research
Pinellas, Florida, United States, 33782-4533
United States, Indiana
Concentrics Center for Research
Indianapolis, Indiana, United States, 46240
United States, Oregon
Cyn3rgy Research
Gresham, Oregon, United States, 97030
United States, Tennessee
Clinical Research Associates Incorporated
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Pfizer
AccuDial Pharmaceutical
Boehringer Ingelheim
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Novartis
Perrigo Company
Procter and Gamble
Reckitt Benckiser LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01257542     History of Changes
Other Study ID Numbers: A6531001, RB-10-12
Study First Received: December 7, 2010
Results First Received: August 21, 2012
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
randomized
parallel
double-blind
placebo-controlled
cough
efficacy
safety
dextromethorphan

Additional relevant MeSH terms:
Common Cold
Respiratory Tract Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection
Dextromethorphan
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Respiratory System Agents

ClinicalTrials.gov processed this record on July 22, 2014