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Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

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

Summary

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.

Description

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

Conditions

Acetaminophen Overdose

Intervention

Acetadote EF, Acetadote

Status

Not yet recruiting

Source

Cumberland Pharmaceuticals

Results (where available)

View Results

Links

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

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PubMed Articles [296 Associated PubMed Articles listed on BioPortfolio]

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

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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.

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