Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
- Conditions
- Acute Upper Respiratory Track Infection
- Interventions
- Device: Placebo
- Registration Number
- NCT01202279
- Lead Sponsor
- Reckitt Benckiser Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1179
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo given bid with a full glass of water for 7 days Mucinex D Guaifenesin 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
- Primary Outcome Measures
Name Time Method Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21). 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.
Antibiotic Sparing Day 7 Number of patients who received an antibiotic
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Coastal Connecticut Research, LLC, 342 Montauk Avenue
🇺🇸New London, Connecticut, United States
Clinical Associates Research, 750 Main Street, Suite 310
🇺🇸Reisterstown, Maryland, United States
Clinical Research Advantage, Inc.
🇺🇸Mesa, Arizona, United States
Med Center
🇺🇸Carmichael, California, United States
Research Center of Fresno, 3636 N. First Street, Suite 141
🇺🇸Fresno, California, United States
Coastal Medical Research Group, Inc., 47 Santa Rosa Street
🇺🇸San Luis Obispo, California, United States
Glasgow Family Practice
🇺🇸Newark, Delaware, United States
Koch Family Medicine, 81A E. Queenwood Road
🇺🇸Morton, Illinois, United States
Sterling Research Group, Ltd., 650 Sprucewood Lane
🇺🇸Erlanger, Kentucky, United States
Park Place Family Practice & Internal Medicine
🇺🇸Taylor, Michigan, United States
Immedicenter
🇺🇸Bloomfield, New Jersey, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Parsons Avenue Medical Clinic
🇺🇸Columbus, Ohio, United States
Village Health Partners
🇺🇸Plano, Texas, United States
(Piedmont Medical Research Assoc., Inc. d/b/a), Crescent Medical Research
🇺🇸Salisbury, North Carolina, United States
Legacy Clinical Research, LLC, 1204 W. Willow Road, Suite B
🇺🇸Enid, Oklahoma, United States
Kastelic MD & Associates, 322 Warren Street, Suite 300
🇺🇸Johnstown, Pennsylvania, United States
Integrated Medical Research, PC
🇺🇸Ashland, Oregon, United States
Harleysville Medical Associates, 176 Main Street
🇺🇸Harleysville, Pennsylvania, United States
Durham Physicians, P.C.
🇺🇸Penndel, Pennsylvania, United States
Palmetto Medical Research, 180 Wingo Way, Suite 203
🇺🇸Mount Pleasant, South Carolina, United States
TriCities Medical Research
🇺🇸Bristol, Tennessee, United States
Independence Family Medicine, 813 Independence Blvd., Suite A
🇺🇸Virginia Beach, Virginia, United States
Amherst Family Practice, 1867 Amherst Street
🇺🇸Winchester, Virginia, United States