Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI (Wait and See)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Reckitt Benckiser LLC

ClinicalTrials.gov Identifier:

NCT01202279

First received: September 13, 2010

Last updated: October 4, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 13, 2010
Last Updated Date	October 4, 2012
Start Date ^ICMJE	October 2009
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 4, 2012)	Antibiotic Sparing [ Time Frame: Day 7 ] [ Designated as safety issue: No ] Number of patients who received an antibiotic Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21). [ Time Frame: Baseline and 7 Days ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE (submitted: September 13, 2010)	Overall Symptom Relief [ Time Frame: Day 4 ] [ Designated as safety issue: No ] Percentage of pts reporting overall relief at day 4 based on pt's IVRS daily diary entry
Change History	Complete list of historical versions of study NCT01202279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Acute Upper Respiratory Track Infection
Intervention ^ICMJE	Drug: Guaifenesin 1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days Other Names: Mucinex D Mucinex Guaifenesin Pseudoephedrine Device: Placebo Placebo bid for 7 days Other Name: Placebo
Study Arm (s)	Active Comparator: Mucinex D 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 Intervention: Drug: Guaifenesin Placebo Comparator: Placebo Placebo given bid with a full glass of water for 7 days Intervention: Device: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1189
Completion Date	July 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01202279
Other Study ID Numbers ^ICMJE	2009-MUCD-001
Has Data Monitoring Committee	No
Responsible Party	Reckitt Benckiser LLC
Study Sponsor ^ICMJE	Reckitt Benckiser LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Reckitt Benckiser LLC
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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