Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

Stopped early · Phase 3

Conditions studied: Acetaminophen Overdose

In brief

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.

Key facts

Study ID

NCT01118663

Run by

Cumberland Pharmaceuticals

People needed

17

Starts

2010-09-01

Expected to finish

2013-05-01

Last updated by the study team

2014-08-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any subject requiring treatment with acetylcysteine for acute acetaminophen toxicity

You may not qualify if…

• History of allergy or hypersensitivity to acetylcysteine or any component of Acetadote.
• Exposed to investigational drugs within 30 days before Clinical Trial Material (CTM) administration.
• Pregnant or nursing.
• Less than 12 years of age.
• Have a baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1000 U/L.
• Have a baseline International Normalized. Ratio (INR) > 2.0
• 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.
• 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.
• 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).
• Refusal to provide written authorization for use and disclosure of protected health information.
• Be otherwise unsuitable for the study, in the opinion of the Investigator.

Where it is running

• Maricopa Medical Center — Phoenix, Arizona, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• UCSD Medical Center — San Diego, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• LSU Health Sciences Center - Shreveport — Shreveport, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Spectrum Health Butterworth Hospital — Grand Rapids, Michigan, United States
• East Carolina University Medical Center — Greenville, North Carolina, United States
• Toledo Hospital — Toledo, Ohio, United States
• Scott & White Medical Center — Temple, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.