Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI (Wait and See)

December 3, 2020 updated by: Reckitt Benckiser Inc.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Safety and Efficacy of Mucinex D for Symptomatic Therapy in Patients With Acute Upper Respiratory Tract Who Seek Treatment

The purpose of this study is to determine if treatment with Mucinex D lowers the use of antibiotics in the treatment of upper respiratory infection when compared to placebo

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1179

Phase

  • Phase 4

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
    • Arizona
      • Mesa, Arizona, United States, 85203
        • Clinical Research Advantage, Inc.
    • California
      • Carmichael, California, United States, 95608
        • Med Center
      • Fresno, California, United States, 93726
        • Research Center of Fresno, 3636 N. First Street, Suite 141
      • San Luis Obispo, California, United States, 93405
        • Coastal Medical Research Group, Inc., 47 Santa Rosa Street
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Coastal Connecticut Research, LLC, 342 Montauk Avenue
    • Delaware
      • Newark, Delaware, United States, 19702
        • Glasgow Family Practice
    • Illinois
      • Morton, Illinois, United States, 61550
        • Koch Family Medicine, 81A E. Queenwood Road
    • Kentucky
      • Erlanger, Kentucky, United States, 41018
        • Sterling Research Group, Ltd., 650 Sprucewood Lane
    • Maryland
      • Reisterstown, Maryland, United States, 21136
        • Clinical Associates Research, 750 Main Street, Suite 310
    • Michigan
      • Taylor, Michigan, United States, 48180
        • Park Place Family Practice & Internal Medicine
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Immedicenter
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research
      • Salisbury, North Carolina, United States, 28144
        • (Piedmont Medical Research Assoc., Inc. d/b/a), Crescent Medical Research
    • Ohio
      • Columbus, Ohio, United States, 43207
        • Parsons Avenue Medical Clinic
    • Oklahoma
      • Enid, Oklahoma, United States, 73703
        • Legacy Clinical Research, LLC, 1204 W. Willow Road, Suite B
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Integrated Medical Research, PC
    • Pennsylvania
      • Harleysville, Pennsylvania, United States, 19438
        • Harleysville Medical Associates, 176 Main Street
      • Johnstown, Pennsylvania, United States, 15905
        • Kastelic MD & Associates, 322 Warren Street, Suite 300
      • Penndel, Pennsylvania, United States, 19047
        • Durham Physicians, P.C.
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Palmetto Medical Research, 180 Wingo Way, Suite 203
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Tricities Medical Research
    • Texas
      • Plano, Texas, United States, 75024
        • Village Health Partners
    • Virginia
      • Virginia Beach, Virginia, United States, 23455
        • Independence Family Medicine, 813 Independence Blvd., Suite A
      • Winchester, Virginia, United States, 22601
        • Amherst Family Practice, 1867 Amherst Street

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients aged 18 to 75 yrs of age presenting at a clinical site with symptoms diagnostic for an acute upper respiratory tract infection within the last 5 days

Exclusion Criteria:

  • patients who had chronic, recurring respiratory signs and symptoms due to conditions such as chronic allergic rhinitis, chronic sinusitis or chronic bronchitis which in the investigator's opinion, confounded interpretation of symptom ratings for the acute upper respiratory infection. Also excluded were patients with a fever greater than 101 degrees F.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mucinex D
Mucinex D (1200 mg guaifenesin and 120 mg pseudoephedrine HCl) extended release bilayer tablet twice a day (bid) with a full glass of water for 7 days
Drug: Guaifenesin
1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days
Other Names:
  • Mucinex D
  • Mucinex
  • Pseudoephedrine
Placebo Comparator: Placebo
Placebo given bid with a full glass of water for 7 days
Device: Placebo
Placebo bid for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic Sparing
Time Frame: Day 7
Number of patients who received an antibiotic
Day 7
Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).
Time Frame: Baseline and 7 Days
WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.
Baseline and 7 Days

Collaborators and Investigators

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

Sponsor

Reckitt Benckiser Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (Estimate)

September 15, 2010

Study Record Updates

Last Update Posted (Actual)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-MUCD-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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