TerminatedPhase 3

Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

United States17 participantsStarted 2010-09

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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Exclusion criteria

✕. 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.

What they're measuring

The Incidence of Hepatoxicity as Measured by the Percentage of Subjects With an Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Value > 1000 U/L Versus Those With an ALT and AST < 1000 U/L

Timeframe: 21 hours

Trial details

NCT IDNCT01118663

SponsorCumberland Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-11

Results submitted2014-04-15

View on ClinicalTrials.gov More Acetaminophen Overdose trials