Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections - Full Text View

Purpose

The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections.

Condition	Intervention	Phase
Acute Upper Respiratory Tract Infection	Drug: Guaifenesin Drug: IR Guaifenesin Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Randomized, Double-Blind, Double Dummy, Placebo-Controlled Study of the Safety and Efficacy Mucinex (2400 mg/d) and Immediate-Release Guaifenesin (800 mg/d)in the Treatment of Symptoms of Acute Upper Respiratory Tract Infections For 7 Days

Resource links provided by NLM:

MedlinePlus related topics: Common Cold

Drug Information available for: Guaifenesin Phenylpropanolamine hydrochloride Triaminic Phenylpropanolamine

U.S. FDA Resources

Further study details as provided by Reckitt Benckiser LLC:

Study Start Date:	September 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Mucinex and IR guaifenesin placebo Two 600 mg Mucinex bi-layer tablets and one placebo matching 200 mg IR guaifenesin tablet.	Drug: Guaifenesin Two 600 mg Mucinex bi-layer tablets and one placebo matching the 200 mg IR guaifenesin tablet, every 12 hours for 7 days.
Active Comparator: IR guaifenesin and Mucinex placebo One 200 mg IR guaifenesin tablet and two matching 600 mg Mucinex placebo tablets.	Drug: IR Guaifenesin One 200 mg IR guaifenesin tablet and two matching 600 mg Mucinex placebo tablets, every 6 (+/- 2) hours for 7 days.
Placebo Comparator: Mucinex placebo & IR guaifenesin placebo Two matching 600 mg Mucinex placebo tablets combined with one matching 200 mg IR guaifenesin placebo tablet.	Drug: Placebo Two matching 600 mg Mucinex placebo tablets combined with one matching 200 mg IR guaifenesin placebo tablet, every (+/- 2) hours for 7 days.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Has developed cold symptoms within 3 days prior to dosing on Day 1.

Exclusion Criteria:

Chronic illnesses.
Febrile illness > 101 F within 7 days prior to Day 1,
Pregnant.
Known current malignancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537081

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Locations

United States, Alabama
Reckitt Benckiser Study Site
Hoover, Alabama, United States, 35216
United States, California
Reckitt Benckiser Study Site
Bell Gardens, California, United States, 90201
Reckitt Benckiser Study Site
Harbor City, California, United States, 90710
Reckitt Benckiser Study Site
Long Beach, California, United States, 90813
Reckitt Benckiser Study Site
Sacramento, California, United States, 95816
Reckitt Benckiser Study Site
San Francisco, California, United States, 94102
Reckitt Benckiser Study Site
San Luis Obispo, California, United States, 93405
United States, Colorado
Reckitt Benckiser Study Site
Colorado Springs, Colorado, United States, 80907
Reckitt Benckiser Study Site
Denver, Colorado, United States, 80239
United States, Florida
Reckitt Benckiser Study Site
Daytona Beach, Florida, United States, 32117
Reckitt Benckiser Study Site
Edgewater, Florida, United States, 32132
Reckitt Benckiser Study Site
Largo, Florida, United States, 33710
United States, Illinois
Reckitt Benckiser Study Site
Chicago, Illinois, United States, 60624
Reckitt Benckiser Study Site
Normal, Illinois, United States, 61761
United States, Kansas
Reckitt Benckiser Study Site
Wichita, Kansas, United States, 67207
United States, Kentucky
Reckitt Benckiser Study Site
Lexington, Kentucky, United States, 40509
United States, Louisiana
Reckitt Benckiser Study Site
Metairie, Louisiana, United States, 70006
Reckitt Benckiser Study Site
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Reckitt Benckiser Study Site
Brighton, Massachusetts, United States, 02135
Reckitt Benckiser Study Site
Fall River, Massachusetts, United States, 02720
United States, Nebraska
Reckitt Benckiser Study Site
Bellevue, Nebraska, United States, 68005
Reckitt Benckiser Study Site
Omaha, Nebraska, United States, 68134
Reckitt Benckiser Study Site
Omaha, Nebraska, United States, 68114
United States, Nevada
Reckitt Benckiser Study Site
Las Vegas, Nevada, United States, 89102
Reckitt Benckiser Study Site
Las Vegas, Nevada, United States, 89119
United States, New York
Reckitt Benckiser Study Site
Rochester, New York, United States, 14609
United States, North Carolina
Reckitt Benckiser Study Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
Reckitt Benckiser Study Site
Cincinnati, Ohio, United States, 45246
Reckitt Benckiser Study Site
Middleburg Heights, Ohio, United States, 44130
United States, Rhode Island
Reckitt Benckiser Study Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Reckitt Benckiser Study Site
Greer, South Carolina, United States, 29651
United States, South Dakota
Reckitt Benckiser Study Site
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
Reckitt Benckiser Study Site
Franklin, Tennessee, United States, 37067
Reckitt Benckiser Study Site
Jackson, Tennessee, United States, 38305
Reckitt Benckiser Study Site
New Tazewell, Tennessee, United States, 37825
Reckitt Benckiser Study Site
Smyrna, Tennessee, United States, 37167
United States, Texas
Reckitt Benckiser Study Site
Austin, Texas, United States, 78705
Reckitt Benckiser Study Site
Carrollton, Texas, United States, 75010
Reckitt Benckiser Study Site
Forth Worth, Texas, United States, 76135
Reckitt Benckiser Study Site
San Angelo, Texas, United States, 76904
Reckitt Benckiser Study Site
Tomball, Texas, United States, 77375
United States, Utah
Reckitt Benckiser Study Site
Salt Lake City, Utah, United States, 84124
United States, Washington
Reckitt Benckiser Study Site
Spokane, Washington, United States, 99204

Sponsors and Collaborators

Reckitt Benckiser LLC

More Information

No publications provided

Responsible Party:	Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:	NCT01537081 History of Changes
Other Study ID Numbers:	2011-MUC-04
Study First Received:	February 16, 2012
Last Updated:	March 13, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory Tract Infections
Common Cold
Infection
Respiratory Tract Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Guaifenesin
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-Agonists

Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013