You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 24, 2024

CLINICAL TRIALS PROFILE FOR GUAIFENESIN


✉ Email this page to a colleague

« Back to Dashboard


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NCT00000752 ↗ Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn Adams Laboratories Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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NCT00000752 ↗ Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn Glaxo Wellcome Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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.
NCT00377403 ↗ Treatment of Acute Sinusitis Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 4 2006-10-01 This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.
>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
Flu Symptoms 2
Bronchitis 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for guaifenesin
Intervention Trials
Infections 7
Infection 6
Communicable Diseases 5
Respiratory Tract Infections 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for guaifenesin
Location Trials
California 4
Texas 3
Ohio 3
Kentucky 3
Virginia 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for guaifenesin
Clinical Trial Phase Trials
Completed 24
Unknown status 3
Withdrawn 3
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for guaifenesin

Sponsor Name

Sponsor Name for guaifenesin
Sponsor Trials
Reckitt Benckiser LLC 7
Reckitt Benckiser Inc. 5
EMS 3
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for guaifenesin
Sponsor Trials
Industry 31
Other 5
NIH 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.