CLINICAL TRIALS PROFILE FOR ACETADOTE
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505(b)(2) Clinical Trials for Acetadote
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Formulation | NCT01118663 ↗ | Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection | Terminated | Cumberland Pharmaceuticals | Phase 3 | 2010-09-01 | The primary purpose of this study is determine if a new formulation of Acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Acetadote
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00004467 ↗ | Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen | Completed | University of Texas | Phase 3 | 1998-06-01 | OBJECTIVES: I. Determine the safety and efficacy of a short course (72 hours) of intravenous acetylcysteine in patients with acute liver failure for whom no antidote or specific treatment is available. |
| NCT00004467 ↗ | Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen | Completed | University of Texas Southwestern Medical Center | Phase 3 | 1998-06-01 | OBJECTIVES: I. Determine the safety and efficacy of a short course (72 hours) of intravenous acetylcysteine in patients with acute liver failure for whom no antidote or specific treatment is available. |
| NCT00004467 ↗ | Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 3 | 1998-06-01 | OBJECTIVES: I. Determine the safety and efficacy of a short course (72 hours) of intravenous acetylcysteine in patients with acute liver failure for whom no antidote or specific treatment is available. |
| NCT00374088 ↗ | N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study) | Completed | University of Michigan | Phase 2 | 2005-02-01 | The purpose of this study is to determine whether intravenous N-acetylcysteine (also known as Acetadote), an antioxidant medication that has been used for years to treat Tylenol overdose, helps prevent heart dysfunction in the early postoperative period following congenital heart surgery. Children undergoing major heart surgery, such as the arterial switch operation, routinely develop temporary heart dysfunction in the first 12-24 hours after surgery. This heart dysfunction may be severe and contributes to an increased risk for death or prolonged hospitalization. Current standard treatments include intravenous medications such as dopamine, epinephrine, and vasopressin that support your child's blood pressure and heart function. Unfortunately, high doses of these medications have the potential to cause severe side effects including loss of fingers and toes, liver and kidney dysfunction, and heart rhythm abnormalities. Our goal is to find a way to reduce heart dysfunction after major heart surgery in order to promote a smoother postoperative period, and reduce the risks associated with heart operations in children. |
| NCT00397735 ↗ | N-acetylcysteine in Intra-amniotic Infection/Inflammation | Completed | Ohio State University | Phase 1/Phase 2 | 2006-10-01 | The aim of the study is to determine if N-acetylcysteine (a potent free radical scavenger) prevents the occurrence of adverse neonatal outcomes in preterm deliveries complicated by infection associated with preterm labor or preterm premature rupture of membranes (PPROM). The working hypothesis is that in pregnancies complicated by intra-amniotic infection or inflammation, N-acetylcysteine protects the fetus by preventing the development, or decreasing the intensity and/or progression of the fetal inflammatory syndrome. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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