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

Primary Purpose

Acute Upper Respiratory Tract Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mucinex
Immediate-release Guaifenesin
Placebo
Sponsored by
Reckitt Benckiser LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Upper Respiratory Tract Infection

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site
  • Reckitt Benckiser Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Mucinex 2400 mg/day

Immediate-release Guaifenesin 800 mg/Day

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2012
Last Updated
October 22, 2013
Sponsor
Reckitt Benckiser LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01537081
Brief Title
Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reckitt Benckiser LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Respiratory Tract Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2810 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mucinex 2400 mg/day
Arm Type
Experimental
Arm Description
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.
Arm Title
Immediate-release Guaifenesin 800 mg/Day
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mucinex
Other Intervention Name(s)
Mucinex®, guaifenesin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Immediate-release Guaifenesin
Other Intervention Name(s)
IR guaifenesin, IR GGE
Intervention Description
Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water
Primary Outcome Measure Information:
Title
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4
Description
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
Title
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Has developed cold symptoms within 3 days prior to dosing on Day 1. Exclusion Criteria: Chronic illnesses. Febrile illness > 101 F within 7 days prior to Day 1, Pregnant. Known current malignancy.
Facility Information:
Facility Name
Reckitt Benckiser Study Site
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60624
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
New Tazewell
State/Province
Tennessee
ZIP/Postal Code
37825
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Forth Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Reckitt Benckiser Study Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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