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

Information source: Reckitt Benckiser LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Upper Respiratory Track Infection

Intervention: Guaifenesin (Drug); Placebo (Device)

Phase: Phase 4

Status: Completed

Sponsored by: Reckitt Benckiser LLC


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

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Antibiotic Sparing

Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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.

Locations and Contacts

Clinical Research Advantage, Inc., Mesa, Arizona 85203, United States

Glasgow Family Practice, Newark, Delaware 19702, United States

Immedicenter, Bloomfield, New Jersey 07003, United States

Additional Information

Starting date: October 2009
Last updated: October 4, 2012

Page last updated: August 23, 2015

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