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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucinex D | Active Comparator | 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 |
|
| Placebo | Placebo Comparator | Placebo given bid with a full glass of water for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guaifenesin | Drug | 1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Advantage, Inc. | Mesa | Arizona | 85203 | United States | ||
| Med Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28761581 | Derived | 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. |
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Recruitment took place October 2009 through April 2010. Advertising was not allowed for this study. Patients were seen by a Health Care Provider(HCP) and must have been seeking treatment for symptoms diagnostic for an acute upper respiratory tract infection.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mucinex D | Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days |
| FG001 | Placebo | Placebo given bid with a full glass of water for 7 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Device | Placebo bid for 7 days |
|
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mucinex D | Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days |
| BG001 | Placebo | Placebo given bid with a full glass of water for 7 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antibiotic Sparing | Number of patients who received an antibiotic | Per Protocol Population using Fishers Exact Test. | Posted | Number | Participants | Day 7 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 7 Days |
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Upon signing of the informed consent, the patient was requested to report all AEs experienced throughout the duration of their participation in this study. AEs were followed until resolution, stability or until 30 days after last dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mucinex D | Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days | 0 | 593 | 37 | 593 | ||
| EG001 | Placebo | Placebo given bid with a full glass of water for 7 days | 0 | 591 | 21 | 591 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervousness | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Clark | Reckitt Benckiser | 855.966.5483 | ClinicalRequests@rb.com |
| ID | Term |
|---|---|
| D006140 | Guaifenesin |
| D000584 | Amiloride |
| D000111 | Acetylcysteine |
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D006139 | Guaiacol |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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| >=65 years |
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| Male |
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