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CLINICAL TRIALS PROFILE FOR NITROFURANTOIN

Clinical Trials for Nitrofurantoin

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00361998	Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis	Withdrawn	Clalit Health Services	Phase 4	Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI.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NCT00361998	Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis	Withdrawn	HaEmek Medical Center, Israel	Phase 4	Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI.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	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.
NCT00391651	Short Course Nitrofurantoin for Acute Cystitis	Completed	University of Washington	Phase 2	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.
NCT00649285	Food Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg	Completed	Mylan Pharmaceuticals	Phase 1	The objective of this study was to investigate the bioequivalence of Mylan's nitrofurantoin monohydrate/macrocrystals capsules to Procter & Gamble's Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.
NCT00649506	Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules and Macrodantin® 100 mg	Completed	Mylan Pharmaceuticals	Phase 1	The objective of this study was to evaluate the relative bioavailability of Mylan's nitrofurantoin macrocrystals 100 mg capsules to Procter & Gamble's Macrodantin® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose in 28 healthy, adult, non-tobacco using volunteers under fed conditions.
Trial ID	Title	Status	Sponsor	Phase	Summary