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Clinical Trial 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.


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


Related Conditions & MeSH terms


NCT number NCT01118663
Study type Interventional
Source Cumberland Pharmaceuticals
Contact
Status Terminated
Phase Phase 3
Start date September 2010
Completion date May 2013

See also
  Status Clinical Trial Phase
Recruiting NCT05517668 - Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose Phase 2
Completed NCT01592448 - Investigation of Efficacy of Improved Acetaminophen Labeling N/A
Terminated NCT01692639 - Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest? N/A