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Last Updated: October 22, 2021

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CLINICAL TRIALS PROFILE FOR NITROFURANTOIN

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505(b)(2) Clinical Trials for NITROFURANTOIN

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 NCT05055544 ↗ Bearberry in the Treatment of Cystitis Not yet recruiting University of Pecs N/A 2021-10-01 The goal of this study is to assess the efficacy of bearberry in uncomplicated cystitis. Uncomplicated cystitis is a disease related to the infection of the urinary bladder. Typical symptoms are dysuria, urinary urgency, and frequent voiding of small volumes. Urinary tract infections are frequent in women, usually treated with antibiotics, since the disease is usually caused by bacteria. Fosfomycin is a frequently used antibiotic for the treatment of uncomplicated cystitis. This medicine is typically prescribed by MDs. However, since uncomplicated cystitis is quite frequent, not all patients visit the doctor when experiencing the symptoms of this disease. The use of over-the-counter products (medicines and food supplements) to alleviate the symptoms is common. One of the most frequently used medicinal plants for this purpose is bearberry. Bearberry is a medicinal plant traditionally used for the treatment of cystitis. Its use is accepted by the European Medicine Agency as traditional herbal medicinal product for relief of symptoms of mild recurrent lower urinary tract infections such as burning sensation during urination and/or frequent urination in women. Although the experience gained during the traditional use and the laboratory experiments support the supposed beneficial effect of bearberry, its clinical efficacy has not been confirmed in well-designed clinical trials in comparison with standard antibiotic therapy. In this study, the efficacy of bearberry will be assessed in comparison with fosfomycin. Premenopausal women experiencing the symptoms of uncomplicated cystitis will be randomly divided into two groups. Since it will be a double-blind trial, neither the participants nor the experimenters will know who is receiving a particular treatment. In group A, patients will receive a single dose of fosfomycin powder dissolved in water and 2 placebo tablets three times a day for 7 days. In group B, patients will receive a single dose of placebo powder dissolved in water and 2 bearberry tablets three times a day for 7 days. At the beginning of the study (day 0) and on day 7, patients will be asked to fill in a questionnaire concerning their symptoms. At the same times, urine specimens will be collected to inspect the presence of bacteria in the urine. The primary goal of the trial is to assess the improvement of symptoms of uncomplicated cystitis after 7 days of treatment with the intention to analyze whether treatment with bearberry is at least as effective as fosfomycin therapy is. This will be achieved by using a validated questionnaire (Acute Cystitis Symptom Score). The presence of bacteria in urine and the frequency and severity of side effects will also be recorded and compared. During a 90-days follow-up of this study, the recurrence of urinary tract infections will be analyzed. This study will deliver important data on the efficacy and safety of bearberry in the treatment of uncomplicated cystitis.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for NITROFURANTOIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00361998 ↗ Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis Withdrawn Clalit Health Services Phase 4 2006-09-01 Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI. While the length of treatment for uncomplicated cystitis with quinolones or TMP-SMX is three days, NM is recommended for seven days. However, there are not sufficient papers that establish the optimal length of treatment with NM in this population. The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI.
NCT00361998 ↗ Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis Withdrawn HaEmek Medical Center, Israel Phase 4 2006-09-01 Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI. While the length of treatment for uncomplicated cystitis with quinolones or TMP-SMX is three days, NM is recommended for seven days. However, there are not sufficient papers that establish the optimal length of treatment with NM in this population. The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI.
NCT00391651 ↗ Short Course Nitrofurantoin for Acute Cystitis Completed Procter and Gamble Phase 2 2002-01-01 The purpose of this research study is to determine what the cure rates are with a 5 day course of nitrofurantoin versus the more standard 3 day course of trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and what length of therapy is best for treatment of UTI, taking into account the problem of antibiotic resistance. Procedures subjects will undergo once they have read and signed the consent are: Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine sample and then randomly assigned to one of the two treatment groups. will be obtained at each visit. If they were assigned to the nitrofurantoin treatment regimen, they will also be asked to collect a urine sample at home on the third day. If the subject develops recurrent urinary symptoms or does not have resolution of symptoms after completing the initial treatment course, they will be asked to return to the clinic and provide another urine sample for analysis. They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time. The study population is women ages 18-45 with acute symptoms of a UTI without a history of UTI in the past 6 weeks.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NITROFURANTOIN

Condition Name

Condition Name for NITROFURANTOIN
Intervention Trials
Urinary Tract Infections 8
Urinary Tract Infection 5
Healthy 4
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Condition MeSH

Condition MeSH for NITROFURANTOIN
Intervention Trials
Urinary Tract Infections 25
Infection 19
Communicable Diseases 15
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Clinical Trial Locations for NITROFURANTOIN

Trials by Country

Trials by Country for NITROFURANTOIN
Location Trials
United States 29
Spain 5
Pakistan 3
Israel 3
Canada 2
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Trials by US State

Trials by US State for NITROFURANTOIN
Location Trials
California 3
West Virginia 3
North Carolina 3
Tennessee 2
Minnesota 2
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Clinical Trial Progress for NITROFURANTOIN

Clinical Trial Phase

Clinical Trial Phase for NITROFURANTOIN
Clinical Trial Phase Trials
Phase 4 18
Phase 3 3
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for NITROFURANTOIN
Clinical Trial Phase Trials
Recruiting 14
Not yet recruiting 13
Completed 9
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Clinical Trial Sponsors for NITROFURANTOIN

Sponsor Name

Sponsor Name for NITROFURANTOIN
Sponsor Trials
Mylan Pharmaceuticals 3
Mayo Clinic 2
GlaxoSmithKline 2
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Sponsor Type

Sponsor Type for NITROFURANTOIN
Sponsor Trials
Other 57
Industry 10
NIH 1
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