CLINICAL TRIALS PROFILE FOR MACRODANTIN
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All Clinical Trials for MACRODANTIN
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00649506 ↗ | Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules and Macrodantin® 100 mg | Completed | Mylan Pharmaceuticals | Phase 1 | 2003-09-01 | 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. |
| NCT00678041 ↗ | Nitrofurantoin and Urinary Tract Infections (UTIs) | Terminated | University of Pittsburgh | N/A | 2008-05-01 | Urinary tract infection (UTI) is the most common complication after surgery for prolapse or urinary incontinence. UTIs are painful and have the potential to turn into kidney infections. We are asking women who self-catheterize after surgery to try either an antibiotic or a placebo pill so we can see if we can prevent UTIs without causing side effects. This study will not require any additional visits or blood draws. You will be asked to answer some questions, keep a brief diary of your experience, and immediately report any symptoms of a UTI to your doctor. |
| NCT01450800 ↗ | Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI) | Completed | Duke University | Phase 4 | 2011-08-01 | This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients. |
| NCT01966653 ↗ | Study Comparing Nitrofurantoin to Fosfomycin for Acute Urinary Tract Infection in Women | Unknown status | European Commission | Phase 4 | 2013-10-01 | Developed before the establishment of a structured process for drug assessment, nitrofurantoin is now being prescribed frequently given the rise in multi-resistant gram-negative pathogens. Doubts remain regarding fosfomycin's long-term clinical effectiveness. A randomized, controlled trial is needed to explore the clinical effectiveness and better define the side effect profiles of both nitrofurantoin and fosfomycin. This multi-center open trial will randomize 600 non-pregnant women at three international sites (200 each in Poland, Switzerland, and Israel) at increased risk for carriage of resistant uropathogens and with suspicion of uncomplicated lower urinary tract infection to receive either oral nitrofurantoin 100 mg three times daily for 5 days or a single 3g dose of oral fosfomycin. Patients will be followed for clinical and bacteriologic response at days 14 and 28 post therapy completion. The study hypothesis holds that nitrofurantoin will be superior to fosfomycin in clinical efficacy at final follow-up. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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