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CLINICAL TRIALS PROFILE FOR MUCINEX DM

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505(b)(2) Clinical Trials for Mucinex Dm

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00902707	Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung	Completed	Reckitt Benckiser LLC	Phase 1	2009-05-01	The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
OTC	NCT00902707	Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung	Completed	University of North Carolina, Chapel Hill	Phase 1	2009-05-01	The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
OTC	NCT01114581	Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection	Completed	Reckitt Benckiser LLC	Phase 2	2010-04-01	The purpose of this research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections.

All Clinical Trials for Mucinex Dm

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00441246	Phase 4 Study - Mucinex D as Adjunct Therapy	Completed	Adams Respiratory Therapeutics	Phase 4	2007-02-01	The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.
NCT00902707	Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung	Completed	Reckitt Benckiser LLC	Phase 1	2009-05-01	The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
NCT00902707	Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung	Completed	University of North Carolina, Chapel Hill	Phase 1	2009-05-01	The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
NCT01046136	Mucinex Exploratory Cold Study	Completed	Reckitt Benckiser LLC	Phase 2	2009-12-01	This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.
NCT01114581	Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection	Completed	Reckitt Benckiser LLC	Phase 2	2010-04-01	The purpose of this research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections.
NCT01202279	Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI	Completed	Reckitt Benckiser LLC	Phase 4	2009-10-01	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
NCT01537081	Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections	Completed	Reckitt Benckiser LLC	Phase 2/Phase 3	2011-09-01	The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. 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. This design was required based on EU regulatory guidance.

Clinical Trial Conditions for Mucinex Dm

Condition Name

Condition Name for Mucinex Dm
Intervention	Trials
Healthy Subjects	7
Acute Respiratory Infection	2
Acute Upper Respiratory Track Infection	1
Healthy	1

Condition MeSH

Condition MeSH for Mucinex Dm
Intervention	Trials
Respiratory Tract Infections	4
Infection	3
Communicable Diseases	2
Bronchitis	1

Clinical Trial Locations for Mucinex Dm

Trials by Country

Trials by Country for Mucinex Dm
Location	Trials
United States	46
India	1

Trials by US State

Trials by US State for Mucinex Dm
Location	Trials
North Carolina	4
Massachusetts	3
Nebraska	3
California	2
Ohio	2

Clinical Trial Progress for Mucinex Dm

Clinical Trial Phase

Clinical Trial Phase for Mucinex Dm
Clinical Trial Phase	Trials
Phase 4	3
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Mucinex Dm
Clinical Trial Phase	Trials
Completed	14
Recruiting	1

Clinical Trial Sponsors for Mucinex Dm

Sponsor Name

Sponsor Name for Mucinex Dm
Sponsor	Trials
Reckitt Benckiser LLC	9
Reckitt Benckiser Inc.	3
University of North Carolina, Chapel Hill	1

Sponsor Type

Sponsor Type for Mucinex Dm
Sponsor	Trials
Industry	14
Other	2