Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections

Acute Upper Respiratory Tract Infection Clinical Trial

Official title:

Randomized, Double-Blind, Double Dummy, Placebo-Controlled Study of the Safety and Efficacy Mucinex (2400 mg/d) and Immediate-Release Guaifenesin (800 mg/d) in the Treatment of Symptoms of Acute Upper Respiratory Tract Infections For 7 Days

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537081
• Other study ID #: 2011-MUC-04
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 16, 2012
• Last updated: October 22, 2013
• Start date: September 2011
• Est. completion date: July 2012

Study information

• Verified date: October 2013
• Source: Reckitt Benckiser LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design was required based on EU regulatory guidance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2810
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Has developed cold symptoms within 3 days prior to dosing on Day 1.

Exclusion Criteria:

1. Chronic illnesses.

2. Febrile illness > 101 F within 7 days prior to Day 1,

3. Pregnant.

4. Known current malignancy.

Study Design

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

Related Conditions & MeSH terms

• Acute Upper Respiratory Tract Infection
• Infection
• Respiratory Tract Infections

Intervention

Drug:
• Mucinex
Mucinex combines immediate-release (IR) and modified-release guaifenesin in a bilayer tablet. Each tablet was 600 mg of guaifenesin and taken by mouth with a full glass of water.
• Immediate-release Guaifenesin
Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water.
• Placebo
Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water

Locations

Country	Name	City	State
United States	Reckitt Benckiser Study Site	Austin	Texas
United States	Reckitt Benckiser Study Site	Bell Gardens	California
United States	Reckitt Benckiser Study Site	Bellevue	Nebraska
United States	Reckitt Benckiser Study Site	Brighton	Massachusetts
United States	Reckitt Benckiser Study Site	Carrollton	Texas
United States	Reckitt Benckiser Study Site	Chicago	Illinois
United States	Reckitt Benckiser Study Site	Cincinnati	Ohio
United States	Reckitt Benckiser Study Site	Colorado Springs	Colorado
United States	Reckitt Benckiser Study Site	Dakota Dunes	South Dakota
United States	Reckitt Benckiser Study Site	Daytona Beach	Florida
United States	Reckitt Benckiser Study Site	Denver	Colorado
United States	Reckitt Benckiser Study Site	Edgewater	Florida
United States	Reckitt Benckiser Study Site	Fall River	Massachusetts
United States	Reckitt Benckiser Study Site	Forth Worth	Texas
United States	Reckitt Benckiser Study Site	Franklin	Tennessee
United States	Reckitt Benckiser Study Site	Greer	South Carolina
United States	Reckitt Benckiser Study Site	Harbor City	California
United States	Reckitt Benckiser Study Site	Hoover	Alabama
United States	Reckitt Benckiser Study Site	Jackson	Tennessee
United States	Reckitt Benckiser Study Site	Largo	Florida
United States	Reckitt Benckiser Study Site	Las Vegas	Nevada
United States	Reckitt Benckiser Study Site	Las Vegas	Nevada
United States	Reckitt Benckiser Study Site	Lexington	Kentucky
United States	Reckitt Benckiser Study Site	Long Beach	California
United States	Reckitt Benckiser Study Site	Metairie	Louisiana
United States	Reckitt Benckiser Study Site	Middleburg Heights	Ohio
United States	Reckitt Benckiser Study Site	New Orleans	Louisiana
United States	Reckitt Benckiser Study Site	New Tazewell	Tennessee
United States	Reckitt Benckiser Study Site	Normal	Illinois
United States	Reckitt Benckiser Study Site	Omaha	Nebraska
United States	Reckitt Benckiser Study Site	Omaha	Nebraska
United States	Reckitt Benckiser Study Site	Raleigh	North Carolina
United States	Reckitt Benckiser Study Site	Rochester	New York
United States	Reckitt Benckiser Study Site	Sacramento	California
United States	Reckitt Benckiser Study Site	Salt Lake City	Utah
United States	Reckitt Benckiser Study Site	San Angelo	Texas
United States	Reckitt Benckiser Study Site	San Francisco	California
United States	Reckitt Benckiser Study Site	San Luis Obispo	California
United States	Reckitt Benckiser Study Site	Smyrna	Tennessee
United States	Reckitt Benckiser Study Site	Spokane	Washington
United States	Reckitt Benckiser Study Site	Tomball	Texas
United States	Reckitt Benckiser Study Site	Warwick	Rhode Island
United States	Reckitt Benckiser Study Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Reckitt Benckiser LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4	Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.	Day 4	No
Primary	Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5	Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.	Day 5	No