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
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
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 SparingChange From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
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