Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI

Phase 4

Completed

• Conditions: Acute Upper Respiratory Track Infection
• Interventions: Device: Placebo; Drug: Guaifenesin

• 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

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-04
• Study Completion: 2010-07
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-15
• Results First Submitted: 2011-04-04
• Results First Submitted QC: 2012-10-04
• Results First Posted: 2012-11-04
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1179

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 & 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

Trial Locations

Locations (24)

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

Coastal Connecticut Research, LLC, 342 Montauk Avenue; 🇺🇸 New London, Connecticut, 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

Clinical Associates Research, 750 Main Street, Suite 310; 🇺🇸 Reisterstown, Maryland, United States

Park Place Family Practice & Internal Medicine; 🇺🇸 Taylor, Michigan, United States

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