Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

Cumberland Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Acetaminophen Overdose

Treatments: Drug: Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free); Drug: Acetadote

Study type: Interventional

Funder types: Industry

Identifiers

NCT01118663

CPI-NAC-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Any subject requiring treatment with acetylcysteine for acute acetaminophen toxicity

Exclusion criteria

1. History of allergy or hypersensitivity to acetylcysteine or any component of Acetadote.
2. Exposed to investigational drugs within 30 days before Clinical Trial Material (CTM) administration.
3. Pregnant or nursing.
4. Less than 12 years of age.
5. Have a baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1000 U/L.
6. Have a baseline International Normalized. Ratio (INR) > 2.0
7. Be on dialysis or having existing renal injury such that the volume of the study drug administration would render the patient unsuitable for the study, in the opinion of the investigator.
8. Have congestive heart failure such that the volume of the study drug administration would render the patient unsuitable for the study, in the opinion of the investigator.
9. Inability to understand the requirements of the study. Subjects must be willing to provide written informed consent or consent of parent/legal guardian (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions. (If the subject is incapacitated, informed consent will be sought from a legally acceptable representative).
10. Refusal to provide written authorization for use and disclosure of protected health information.
11. Be otherwise unsuitable for the study, in the opinion of the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups

Acetadote without EDTA

Experimental group

Description:

Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]

Treatment:

Drug: Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free)

Acetadote

Active Comparator group

Description:

Acetadote \[Old formulation containing EDTA\]

Treatment:

Drug: Acetadote