Acute Cough Study In Children

NCT ID: NCT01257542

Last Updated: 2012-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Common Cold Infections, Upper Respiratory Tract

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active

Group Type EXPERIMENTAL

Dextromethorphan

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A single 10 mL dose of matching placebo syrup

Interventions

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Dextromethorphan

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

Placebo

A single 10 mL dose of matching placebo syrup

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AccuDial Pharmaceutical, Inc.

OTHER

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

Perrigo Company

INDUSTRY

Sponsor Role collaborator

Procter and Gamble

INDUSTRY

Sponsor Role collaborator

Reckitt Benckiser LLC

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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DMI Research

Pinellas Park, Florida, United States

Site Status

Concentrics Center for Research

Indianapolis, Indiana, United States

Site Status

Cyn3rgy Research

Gresham, Oregon, United States

Site Status

Clinical Research Associates Incorporated

Nashville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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RB-10-12

Identifier Type: -

Identifier Source: secondary_id

A6531001

Identifier Type: -

Identifier Source: org_study_id