Acute Upper Respiratory Track Infection Clinical Trial
— Wait and SeeOfficial title:
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
| Verified date | December 2020 |
| Source | Reckitt Benckiser LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 1179 |
| Est. completion date | July 2010 |
| Est. primary completion date | April 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Integrated Medical Research, PC | Ashland | Oregon |
| United States | Immedicenter | Bloomfield | New Jersey |
| United States | TriCities Medical Research | Bristol | Tennessee |
| United States | Med Center | Carmichael | California |
| United States | Parsons Avenue Medical Clinic | Columbus | Ohio |
| United States | Legacy Clinical Research, LLC, 1204 W. Willow Road, Suite B | Enid | Oklahoma |
| United States | Sterling Research Group, Ltd., 650 Sprucewood Lane | Erlanger | Kentucky |
| United States | Research Center of Fresno, 3636 N. First Street, Suite 141 | Fresno | California |
| United States | Harleysville Medical Associates, 176 Main Street | Harleysville | Pennsylvania |
| United States | Peters Medical Research | High Point | North Carolina |
| United States | Kastelic MD & Associates, 322 Warren Street, Suite 300 | Johnstown | Pennsylvania |
| United States | Clinical Research Advantage, Inc. | Mesa | Arizona |
| United States | Koch Family Medicine, 81A E. Queenwood Road | Morton | Illinois |
| United States | Palmetto Medical Research, 180 Wingo Way, Suite 203 | Mount Pleasant | South Carolina |
| United States | Coastal Connecticut Research, LLC, 342 Montauk Avenue | New London | Connecticut |
| United States | Glasgow Family Practice | Newark | Delaware |
| United States | Durham Physicians, P.C. | Penndel | Pennsylvania |
| United States | Village Health Partners | Plano | Texas |
| United States | Clinical Associates Research, 750 Main Street, Suite 310 | Reisterstown | Maryland |
| United States | (Piedmont Medical Research Assoc., Inc. d/b/a), Crescent Medical Research | Salisbury | North Carolina |
| United States | Coastal Medical Research Group, Inc., 47 Santa Rosa Street | San Luis Obispo | California |
| United States | Park Place Family Practice & Internal Medicine | Taylor | Michigan |
| United States | Independence Family Medicine, 813 Independence Blvd., Suite A | Virginia Beach | Virginia |
| United States | Amherst Family Practice, 1867 Amherst Street | Winchester | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Reckitt Benckiser Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Antibiotic Sparing | Number of patients who received an antibiotic | Day 7 | |
| Primary | 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 |