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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01537081
Other study ID # 2011-MUC-04
Secondary ID
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


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
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