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Last Updated: May 28, 2022

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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NCT00000752 ↗ Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn Adams Laboratories Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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NCT00000752 ↗ Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn Glaxo Wellcome Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Guaifenesin

Condition Name

Condition Name for Guaifenesin
Intervention Trials
Healthy Subjects 9
Cough 5
Bronchitis 2
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Condition MeSH

Condition MeSH for Guaifenesin
Intervention Trials
Infections 7
Infection 6
Respiratory Tract Infections 5
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Clinical Trial Locations for Guaifenesin

Trials by Country

Trials by Country for Guaifenesin
Location Trials
United States 51
Brazil 6
Peru 2
Jordan 2
Canada 1
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Trials by US State

Trials by US State for Guaifenesin
Location Trials
California 4
Ohio 3
Kentucky 3
Texas 3
Pennsylvania 2
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Clinical Trial Progress for Guaifenesin

Clinical Trial Phase

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

Clinical Trial Status for Guaifenesin
Clinical Trial Phase Trials
Completed 24
Unknown status 3
Withdrawn 3
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Clinical Trial Sponsors for Guaifenesin

Sponsor Name

Sponsor Name for Guaifenesin
Sponsor Trials
Reckitt Benckiser LLC 7
Reckitt Benckiser Inc. 5
EMS 3
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Sponsor Type

Sponsor Type for Guaifenesin
Sponsor Trials
Industry 31
Other 5
NIH 2
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