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Last Updated: May 17, 2022

CLINICAL TRIALS PROFILE FOR ACETADOTE


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505(b)(2) Clinical Trials for Acetadote

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
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 >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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Acetadote

Condition Name

Condition Name for Acetadote
Intervention Trials
Radiocontrast Nephropathy 1
Acute Liver Failure 1
Mucinous Tumor 1
Relapse 1
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Condition MeSH

Condition MeSH for Acetadote
Intervention Trials
Kidney Diseases 2
Ischemia 2
Adenocarcinoma 1
Purpura 1
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Clinical Trial Locations for Acetadote

Trials by Country

Trials by Country for Acetadote
Location Trials
United States 35
Netherlands 1
Belgium 1
United Kingdom 1
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Trials by US State

Trials by US State for Acetadote
Location Trials
Michigan 3
California 3
Massachusetts 3
Louisiana 2
Ohio 2
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Clinical Trial Progress for Acetadote

Clinical Trial Phase

Clinical Trial Phase for Acetadote
Clinical Trial Phase Trials
Phase 4 1
Phase 3 4
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Acetadote
Clinical Trial Phase Trials
Completed 7
Not yet recruiting 3
Active, not recruiting 1
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Clinical Trial Sponsors for Acetadote

Sponsor Name

Sponsor Name for Acetadote
Sponsor Trials
Cumberland Pharmaceuticals 3
Centre Hospitalier Universitaire Saint Pierre 1
ZonMw: The Netherlands Organisation for Health Research and Development 1
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Sponsor Type

Sponsor Type for Acetadote
Sponsor Trials
Other 38
Industry 4
NIH 2
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Express Scripts

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