CLINICAL TRIALS PROFILE FOR GUAIFENESIN
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505(b)(2) Clinical Trials for GUAIFENESIN
| 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 | >Sponsor | >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| NCT00000752 ↗ | Preventing Frequent Sinus Infections in HIV-Infected Patients | Withdrawn | Adams Laboratories | Phase 2 | 1969-12-31 | To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and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| NCT00000752 ↗ | Preventing Frequent Sinus Infections in HIV-Infected Patients | Withdrawn | Glaxo Wellcome | Phase 2 | 1969-12-31 | To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a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. |
| NCT00377403 ↗ | Treatment of Acute Sinusitis | Completed | Washington University School of Medicine | 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. |
| 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 |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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