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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01537081
First received: February 16, 2012
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Acute Upper Respiratory Tract Infection
Drug: Mucinex
Drug: Immediate-release Guaifenesin
Drug: Placebo
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser LLC:

Primary Outcome Measures:
  • Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    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.

  • Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    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.


Enrollment: 2810
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Mucinex®
  • guaifenesin
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: 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
Drug: Placebo
Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537081

  Hide Study Locations
Locations
United States, Alabama
Reckitt Benckiser Study Site
Hoover, Alabama, United States, 35216
United States, California
Reckitt Benckiser Study Site
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
United States, Colorado
Reckitt Benckiser Study Site
Colorado Springs, Colorado, United States, 80907
Reckitt Benckiser Study Site
Denver, Colorado, United States, 80239
United States, Florida
Reckitt Benckiser Study Site
Daytona Beach, Florida, United States, 32117
Reckitt Benckiser Study Site
Edgewater, Florida, United States, 32132
Reckitt Benckiser Study Site
Largo, Florida, United States, 33710
United States, Illinois
Reckitt Benckiser Study Site
Chicago, Illinois, United States, 60624
Reckitt Benckiser Study Site
Normal, Illinois, United States, 61761
United States, Kansas
Reckitt Benckiser Study Site
Wichita, Kansas, United States, 67207
United States, Kentucky
Reckitt Benckiser Study Site
Lexington, Kentucky, United States, 40509
United States, Louisiana
Reckitt Benckiser Study Site
Metairie, Louisiana, United States, 70006
Reckitt Benckiser Study Site
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Reckitt Benckiser Study Site
Brighton, Massachusetts, United States, 02135
Reckitt Benckiser Study Site
Fall River, Massachusetts, United States, 02720
United States, Nebraska
Reckitt Benckiser Study Site
Bellevue, Nebraska, United States, 68005
Reckitt Benckiser Study Site
Omaha, Nebraska, United States, 68134
Reckitt Benckiser Study Site
Omaha, Nebraska, United States, 68114
United States, Nevada
Reckitt Benckiser Study Site
Las Vegas, Nevada, United States, 89102
Reckitt Benckiser Study Site
Las Vegas, Nevada, United States, 89119
United States, New York
Reckitt Benckiser Study Site
Rochester, New York, United States, 14609
United States, North Carolina
Reckitt Benckiser Study Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
Reckitt Benckiser Study Site
Cincinnati, Ohio, United States, 45246
Reckitt Benckiser Study Site
Middleburg Heights, Ohio, United States, 44130
United States, Rhode Island
Reckitt Benckiser Study Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Reckitt Benckiser Study Site
Greer, South Carolina, United States, 29651
United States, South Dakota
Reckitt Benckiser Study Site
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
Reckitt Benckiser Study Site
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
United States, Texas
Reckitt Benckiser Study Site
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
United States, Utah
Reckitt Benckiser Study Site
Salt Lake City, Utah, United States, 84124
United States, Washington
Reckitt Benckiser Study Site
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Reckitt Benckiser LLC
  More Information

No publications provided

Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01537081     History of Changes
Other Study ID Numbers: 2011-MUC-04
Study First Received: February 16, 2012
Results First Received: July 3, 2013
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Guaifenesin
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 01, 2014