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CLINICAL TRIALS PROFILE FOR GUAIFENESIN

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505(b)(2) Clinical Trials for Guaifenesin

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	NCT02157649	Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin	Completed	Nexgen Pharma, Inc	Phase 1	2014-06-01	The objectives of this study are (a) to determine if drug levels from a single dose of an extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given every four hours containing lower doses considered safe for over-the-counter use; (b) to evaluate if food affects the drug levels of this extended-release Codeine/Guaifenesin tablet after a single administration; and (c) to assess the safety and tolerability of the Codeine/Guaifenesin extended-release and immediate release tablet formulations.

All Clinical Trials for Guaifenesin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000752	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Adams Laboratories	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00000752	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00000752	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00857987	Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections.	Unknown status	Azidus Brasil	Phase 3	2010-04-01	Evaluate the improvement of the common cold with the use of medication
NCT01062256	Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	N/A	2010-01-01	The objectives of this study are: a) to assess the feasibility and sensitivity of manually count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and severity of acute cough due to upper respiratory tract infection and c) to evaluate the correlation between cough bout frequency and subjective assessments of cough severity. The hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release guaifenesin will significantly reduce the frequency and severity of cough compared to placebo over a 4-hour evaluation period.
NCT01085721	Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections	Unknown status	Mantecorp Industria Quimica e Farmaceutica Ltd.	Phase 3	1969-12-31	Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms during viral infections of the upper respiratory tract. Also, allergic rhinitis makes the mucosa more reactive to infectious agents and potentiates mucus production. The combination of dexchlorpheniramine, pseudoephedrine and guaifenesin elicits antihistaminic, decongestant and expectorant effects. The study hypothesizes is that this product is superior to dexchlorpheniramine alone in the relief of allergic symptoms and in promoting mucus elimination in atopic patients with viral infections of the upper respiratory tract.
NCT01119534	Comparative Efficacy of the Suppository Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Cough Due the Infectious Origin	Unknown status	Azidus Brasil	Phase 3	2011-05-01	It is believed that the suppository consisting of guaiacol, menthol, camphor and eucalyptol, by their pharmacological properties already established for each component, has the ability to reduce the signs and symptoms related to upper respiratory infections in a manner equivalent (not inferior) to medicine used as a comparator in this study and higher than the suppository containing only guaiacol concentration of 12.5 mg.

Clinical Trial Conditions for Guaifenesin

Condition Name

Condition Name for Guaifenesin
Intervention	Trials
Healthy Subjects	9
Cough	4
Bronchitis	2
Flu Symptoms	2

Condition MeSH

Condition MeSH for Guaifenesin
Intervention	Trials
Infection	6
Communicable Diseases	5
Respiratory Tract Infections	4
Cough	3

Clinical Trial Locations for Guaifenesin

Trials by Country

Trials by Country for Guaifenesin
Location	Trials
United States	34
Brazil	6
Peru	2
Jordan	2
India	1

Trials by US State

Trials by US State for Guaifenesin
Location	Trials
California	3
New York	2
Utah	2
Texas	2
Ohio	2

Clinical Trial Progress for Guaifenesin

Clinical Trial Phase

Clinical Trial Phase for Guaifenesin
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Guaifenesin
Clinical Trial Phase	Trials
Completed	17
Not yet recruiting	4
Unknown status	4

Clinical Trial Sponsors for Guaifenesin

Sponsor Name

Sponsor Name for Guaifenesin
Sponsor	Trials
Reckitt Benckiser LLC	7
Reckitt Benckiser Inc.	4
EMS	3

Sponsor Type

Sponsor Type for Guaifenesin
Sponsor	Trials
Industry	30
Other	3
NIH	1