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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,810
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.
Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water.
Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water
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.
Time frame: Day 4
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.
Time frame: Day 5
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Reckitt Benckiser Study Site
Hoover, Alabama, United States
Reckitt Benckiser Study Site
Bell Gardens, California, United States
Reckitt Benckiser Study Site
Harbor City, California, United States
Reckitt Benckiser Study Site
Long Beach, California, United States
Reckitt Benckiser Study Site
Sacramento, California, 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
Colorado Springs, Colorado, United States
Reckitt Benckiser Study Site
Denver, Colorado, United States
Reckitt Benckiser Study Site
Daytona Beach, Florida, United States
...and 33 more locations