Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

2014-08-27 03:13:53 | BioPortfolio


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.


The primary objective of this study is to demonstrate non-inferiority of efficacy determined by the proportion of subjects who develop hepatotoxicity when treated with a new formulation of Acetadote and the proposed new dosing regimen compared to the rate of hepatotoxicity with the current formulation of Acetadote and the current dosing regimen.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Acetaminophen Overdose


Acetadote EF, Acetadote


Not yet recruiting


Cumberland Pharmaceuticals

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:53-0400

Clinical Trials [245 Associated Clinical Trials listed on BioPortfolio]

Effect of Intravenous Acetadote on Incidence of Contrast Induced Nephropathy

In patients undergoing coronary angiography, the incidence of contrast induced nephropathy(CIN)varies widely and ranges from < 5% in the lowest risk patients, to nearly 50% in the highest ...

Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days

Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins i...

Measurement of Nitrotyrosine and Cytokines in Acetaminophen Overdose Patients

The study will examine all levels of cytokines and nitrotyrosine in patients with acetaminophen overdose. Comparisons will be made between cytokine levels and nitrotyrosine levels and the ...

PP100-01 (Calmangafodipir) for Overdose of Paracetamol

Investigate the safety and tolerability of PP100-01 add-on treatment to the 12hr NAC treatment regime in patients treated for paracetamol/acetaminophen overdose (POD) when NAC treatment is...

Acetaminophen-Induced Hepatotoxicity in Chronic Alcohol Abusers

It is widely believed that people who abuse alcohol can sustain a liver injury after taking doses of acetaminophen just above the recommended maximum dose. This study is designed to look ...

PubMed Articles [296 Associated PubMed Articles listed on BioPortfolio]

Novel Protective Role of Nicotinamide Phosphoribosyltransferase in Acetaminophen-Induced Acute Liver Injury in Mice.

Acetaminophen overdose is the most common cause of acute liver injury (ALI) or acute liver failure in the US. Its pathogenetic mechanisms are incompletely understood. Additional studies are warranted ...

TRPV1 mediates the anticonvulsant effects of acetaminophen in mice.

Acetaminophen is one of the most commonly used analgesic and antipyretic drugs. It has been reported that acetaminophen has anticonvulsant effects in several animal models of seizure. An active metabo...

Calculated decisions: Acetaminophen Overdose and N-Acetylcysteine (NAC) Dosing

Multiple Admissions for Acetaminophen (APAP) Overdose: APAP Frequent Fliers, a New Entity?

Polymorphic Expression of UGT1A9 is Associated with Variable Acetaminophen Glucuronidation in Neonates: A Population Pharmacokinetic and Pharmacogenetic Study.

Acetaminophen (paracetamol, APAP) is widely used as an analgesic and antipyretic drug in children and neonates. A number of enzymes contribute to the metabolism of acetaminophen, and genetic factors m...

Medical and Biotech [MESH] Definitions

Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.

A catatoxic steroid and microsomal enzyme inducer having significant effects on the induction of cytochrome P450. It has also demonstrated the potential for protective capability against acetaminophen-induced liver damage.

An accidental or deliberate dose of a medication or street drug that is in excess of what is normally used.

Accidental or deliberate use of a medication or street drug in excess of normal dosage.

A CNS stimulant that is used to induce convulsions in experimental animals. It has also been used as a respiratory stimulant and in the treatment of barbiturate overdose.

More From BioPortfolio on "Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection"

Quick Search


Relevant Topics

Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Searches Linking to this Trial