Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
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
1 other identifier
interventional
2,810
1 country
43
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2011
Shorter than P25 for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
February 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
September 12, 2013
CompletedNovember 14, 2013
October 1, 2013
6 months
February 16, 2012
July 3, 2013
October 22, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (3)
Mucinex 2400 mg/day
EXPERIMENTALThe study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600 mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
Immediate-release Guaifenesin 800 mg/Day
ACTIVE COMPARATORThe dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
Placebo
PLACEBO COMPARATORDouble dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
Interventions
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
Eligibility Criteria
You may qualify if:
- \. Has developed cold symptoms within 3 days prior to dosing on Day 1.
You may not qualify if:
- Chronic illnesses.
- Febrile illness \> 101 F within 7 days prior to Day 1,
- Pregnant.
- Known current malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Reckitt Benckiser Study Site
Hoover, Alabama, 35216, United States
Reckitt Benckiser Study Site
Bell Gardens, California, 90201, United States
Reckitt Benckiser Study Site
Harbor City, California, 90710, United States
Reckitt Benckiser Study Site
Long Beach, California, 90813, United States
Reckitt Benckiser Study Site
Sacramento, California, 95816, United States
Reckitt Benckiser Study Site
San Francisco, California, 94102, United States
Reckitt Benckiser Study Site
San Luis Obispo, California, 93405, United States
Reckitt Benckiser Study Site
Colorado Springs, Colorado, 80907, United States
Reckitt Benckiser Study Site
Denver, Colorado, 80239, United States
Reckitt Benckiser Study Site
Daytona Beach, Florida, 32117, United States
Reckitt Benckiser Study Site
Edgewater, Florida, 32132, United States
Reckitt Benckiser Study Site
Largo, Florida, 33710, United States
Reckitt Benckiser Study Site
Chicago, Illinois, 60624, United States
Reckitt Benckiser Study Site
Normal, Illinois, 61761, United States
Reckitt Benckiser Study Site
Wichita, Kansas, 67207, United States
Reckitt Benckiser Study Site
Lexington, Kentucky, 40509, United States
Reckitt Benckiser Study Site
Metairie, Louisiana, 70006, United States
Reckitt Benckiser Study Site
New Orleans, Louisiana, 70115, United States
Reckitt Benckiser Study Site
Brighton, Massachusetts, 02135, United States
Reckitt Benckiser Study Site
Fall River, Massachusetts, 02720, United States
Reckitt Benckiser Study Site
Bellevue, Nebraska, 68005, United States
Reckitt Benckiser Study Site
Omaha, Nebraska, 68114, United States
Reckitt Benckiser Study Site
Omaha, Nebraska, 68134, United States
Reckitt Benckiser Study Site
Las Vegas, Nevada, 89102, United States
Reckitt Benckiser Study Site
Las Vegas, Nevada, 89119, United States
Reckitt Benckiser Study Site
Rochester, New York, 14609, United States
Reckitt Benckiser Study Site
Raleigh, North Carolina, 27607, United States
Reckitt Benckiser Study Site
Cincinnati, Ohio, 45246, United States
Reckitt Benckiser Study Site
Middleburg Heights, Ohio, 44130, United States
Reckitt Benckiser Study Site
Warwick, Rhode Island, 02886, United States
Reckitt Benckiser Study Site
Greer, South Carolina, 29651, United States
Reckitt Benckiser Study Site
Dakota Dunes, South Dakota, 57049, United States
Reckitt Benckiser Study Site
Franklin, Tennessee, 37067, United States
Reckitt Benckiser Study Site
Jackson, Tennessee, 38305, United States
Reckitt Benckiser Study Site
New Tazewell, Tennessee, 37825, United States
Reckitt Benckiser Study Site
Smyrna, Tennessee, 37167, United States
Reckitt Benckiser Study Site
Austin, Texas, 78705, United States
Reckitt Benckiser Study Site
Carrollton, Texas, 75010, United States
Reckitt Benckiser Study Site
Forth Worth, Texas, 76135, United States
Reckitt Benckiser Study Site
San Angelo, Texas, 76904, United States
Reckitt Benckiser Study Site
Tomball, Texas, 77375, United States
Reckitt Benckiser Study Site
Salt Lake City, Utah, 84124, United States
Reckitt Benckiser Study Site
Spokane, Washington, 99204, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gail Solomon,MS; Director Clinical Development
- Organization
- Reckitt Benckiser LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2012
First Posted
February 22, 2012
Study Start
September 1, 2011
Primary Completion
March 1, 2012
Study Completion
July 1, 2012
Last Updated
November 14, 2013
Results First Posted
September 12, 2013
Record last verified: 2013-10