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

October 22, 2013 updated by: Reckitt Benckiser LLC

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2810

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hoover, Alabama, United States, 35216
        • Reckitt Benckiser Study Site
    • California
      • Bell Gardens, California, United States, 90201
        • Reckitt Benckiser Study Site
      • Harbor City, California, United States, 90710
        • Reckitt Benckiser Study Site
      • Long Beach, California, United States, 90813
        • Reckitt Benckiser Study Site
      • Sacramento, California, United States, 95816
        • Reckitt Benckiser Study Site
      • San Francisco, California, United States, 94102
        • Reckitt Benckiser Study Site
      • San Luis Obispo, California, United States, 93405
        • Reckitt Benckiser Study Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Reckitt Benckiser Study Site
      • Denver, Colorado, United States, 80239
        • Reckitt Benckiser Study Site
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Reckitt Benckiser Study Site
      • Edgewater, Florida, United States, 32132
        • Reckitt Benckiser Study Site
      • Largo, Florida, United States, 33710
        • Reckitt Benckiser Study Site
    • Illinois
      • Chicago, Illinois, United States, 60624
        • Reckitt Benckiser Study Site
      • Normal, Illinois, United States, 61761
        • Reckitt Benckiser Study Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Reckitt Benckiser Study Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Reckitt Benckiser Study Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Reckitt Benckiser Study Site
      • New Orleans, Louisiana, United States, 70115
        • Reckitt Benckiser Study Site
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Reckitt Benckiser Study Site
      • Fall River, Massachusetts, United States, 02720
        • Reckitt Benckiser Study Site
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
        • Reckitt Benckiser Study Site
      • Omaha, Nebraska, United States, 68114
        • Reckitt Benckiser Study Site
      • Omaha, Nebraska, United States, 68134
        • Reckitt Benckiser Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Reckitt Benckiser Study Site
      • Las Vegas, Nevada, United States, 89119
        • Reckitt Benckiser Study Site
    • New York
      • Rochester, New York, United States, 14609
        • Reckitt Benckiser Study Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Reckitt Benckiser Study Site
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Reckitt Benckiser Study Site
      • Middleburg Heights, Ohio, United States, 44130
        • Reckitt Benckiser Study Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Reckitt Benckiser Study Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Reckitt Benckiser Study Site
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Reckitt Benckiser Study Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Reckitt Benckiser Study Site
      • Jackson, Tennessee, United States, 38305
        • Reckitt Benckiser Study Site
      • New Tazewell, Tennessee, United States, 37825
        • Reckitt Benckiser Study Site
      • Smyrna, Tennessee, United States, 37167
        • Reckitt Benckiser Study Site
    • Texas
      • Austin, Texas, United States, 78705
        • Reckitt Benckiser Study Site
      • Carrollton, Texas, United States, 75010
        • Reckitt Benckiser Study Site
      • Forth Worth, Texas, United States, 76135
        • Reckitt Benckiser Study Site
      • San Angelo, Texas, United States, 76904
        • Reckitt Benckiser Study Site
      • Tomball, Texas, United States, 77375
        • Reckitt Benckiser Study Site
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Reckitt Benckiser Study Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Reckitt Benckiser Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mucinex 2400 mg/day
The 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.
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.
Other Names:
  • guaifenesin
  • Mucinex®
Drug: Placebo
Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water
Active Comparator: Immediate-release Guaifenesin 800 mg/Day
The 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.
Drug: Placebo
Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water
Drug: Immediate-release Guaifenesin
Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water.
Other Names:
  • IR guaifenesin
  • IR GGE
Placebo Comparator: Placebo
Double 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.
Drug: Placebo
Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reckitt Benckiser LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 16, 2012

First Posted (Estimate)

February 22, 2012

Study Record Updates

Last Update Posted (Estimate)

November 14, 2013

Last Update Submitted That Met QC Criteria

October 22, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-MUC-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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