Clinical trial NCT01257542: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Common Cold
Infections, Upper Respiratory Tract
Keywords: randomized
parallel
double-blind
placebo-controlled
cough
efficacy
safety
dextromethorphan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: AccuDial Pharmaceutical, Inc.
name: Boehringer Ingelheim
name: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
name: Novartis
name: Perrigo Company
name: Procter and Gamble
name: Reckitt Benckiser LLC
First posted: 2010-12-09
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total Cough Count
timeFrame: Up to 6 hours post-dose
Secondary outcomes:
measure: Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period
timeFrame: Baseline, 1, 2, 3, 4, 5, 6 hours post-dose
measure: Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
timeFrame: Baseline, 1, 2, 3, 4, 5, 6 hours
measure: Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period
timeFrame: Baseline, 1, 2, 3, 4, 5, 6 hour post-dose
measure: Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
timeFrame: Baseline, 1, 2, 3, 4, 5, 6 hours
measure: Participants' Global Assessment of Cough: Cough Severity
timeFrame: Within 5 minutes after Hour 6
measure: Participants' Global Assessment of Cough: Relief From Cough
timeFrame: Within 5 minutes after Hour 6
Other outcomes:
Locations:
city: Pinellas
country: United States
facility: DMI Research
state: Florida
city: Indianapolis
country: United States
facility: Concentrics Center for Research
state: Indiana
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Nashville
country: United States
facility: Clinical Research Associates Incorporated
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: