Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
Wait and See
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
1 other identifier
interventional
1,179
1 country
24
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2009
Shorter than P25 for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 13, 2010
CompletedFirst Posted
Study publicly available on registry
September 15, 2010
CompletedResults Posted
Study results publicly available
November 5, 2012
CompletedDecember 30, 2020
December 1, 2020
6 months
September 13, 2010
April 4, 2011
December 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Antibiotic Sparing
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).
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
Study Arms (2)
Mucinex D
ACTIVE COMPARATORMucinex 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
Placebo
PLACEBO COMPARATORPlacebo given bid with a full glass of water for 7 days
Interventions
1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Clinical Research Advantage, Inc.
Mesa, Arizona, 85203, United States
Med Center
Carmichael, California, 95608, United States
Research Center of Fresno, 3636 N. First Street, Suite 141
Fresno, California, 93726, United States
Coastal Medical Research Group, Inc., 47 Santa Rosa Street
San Luis Obispo, California, 93405, United States
Coastal Connecticut Research, LLC, 342 Montauk Avenue
New London, Connecticut, 06320, United States
Glasgow Family Practice
Newark, Delaware, 19702, United States
Koch Family Medicine, 81A E. Queenwood Road
Morton, Illinois, 61550, United States
Sterling Research Group, Ltd., 650 Sprucewood Lane
Erlanger, Kentucky, 41018, United States
Clinical Associates Research, 750 Main Street, Suite 310
Reisterstown, Maryland, 21136, United States
Park Place Family Practice & Internal Medicine
Taylor, Michigan, 48180, United States
Immedicenter
Bloomfield, New Jersey, 07003, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
(Piedmont Medical Research Assoc., Inc. d/b/a), Crescent Medical Research
Salisbury, North Carolina, 28144, United States
Parsons Avenue Medical Clinic
Columbus, Ohio, 43207, United States
Legacy Clinical Research, LLC, 1204 W. Willow Road, Suite B
Enid, Oklahoma, 73703, United States
Integrated Medical Research, PC
Ashland, Oregon, 97520, United States
Harleysville Medical Associates, 176 Main Street
Harleysville, Pennsylvania, 19438, United States
Kastelic MD & Associates, 322 Warren Street, Suite 300
Johnstown, Pennsylvania, 15905, United States
Durham Physicians, P.C.
Penndel, Pennsylvania, 19047, United States
Palmetto Medical Research, 180 Wingo Way, Suite 203
Mt. Pleasant, South Carolina, 29464, United States
TriCities Medical Research
Bristol, Tennessee, 37620, United States
Village Health Partners
Plano, Texas, 75024, United States
Independence Family Medicine, 813 Independence Blvd., Suite A
Virginia Beach, Virginia, 23455, United States
Amherst Family Practice, 1867 Amherst Street
Winchester, Virginia, 22601, United States
Related Publications (1)
Septimus EJ, Albrecht HH, Solomon G, Shea T, Guenin EP. Extended-Release Guaifenesin/Pseudoephedrine Hydrochloride for Symptom Relief in Support of a Wait-and-See Approach for the Treatment of Acute Upper Respiratory Tract Infections: A Randomized, Double-Blind, Placebo-Controlled Study. Curr Ther Res Clin Exp. 2017 Apr 28;84:54-61. doi: 10.1016/j.curtheres.2017.04.004. eCollection 2017.
PMID: 28761581DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kim Clark
- Organization
- Reckitt Benckiser
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2010
First Posted
September 15, 2010
Study Start
October 1, 2009
Primary Completion
April 1, 2010
Study Completion
July 1, 2010
Last Updated
December 30, 2020
Results First Posted
November 5, 2012
Record last verified: 2020-12