Acute Cough Study In Children

NCT01257542 | Terminated Phase 4 Results

• 2 other identifiers: A6531001RB-10-12
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

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.

Conditions

Common Cold; Infections, Upper Respiratory Tract

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

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

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

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

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

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

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

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

• Participants' Global Assessment of Cough: Cough Severity

  Within 5 minutes after Hour 6

Study Arms (2)

Active

EXPERIMENTAL

Drug: Dextromethorphan

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dextromethorphan DRUG

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

Active

Placebo DRUG

A single 10 mL dose of matching placebo syrup

Placebo

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

DMI Research

Pinellas Park, Florida, 33782-4533, United States

Location

Concentrics Center for Research

Indianapolis, Indiana, 46240, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

Clinical Research Associates Incorporated

Nashville, Tennessee, 37203, United States

Location

Related Links

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

MeSH Terms

Conditions

Common Cold; Respiratory Tract Infections; Cough

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Due to methodological issues during study conduct, the study was terminated after only less than 50% of the targeted enrollment was achieved.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 9, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 20, 2012
• Results First Posted: September 20, 2012

Record last verified: 2012-08

Locations

US (4)