1118663
Last Update Posted: 2014-08-04
Recruiting has ended
All Genders accepted | 12 Years + |
17 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection
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.
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.
Eligibility
Relevant conditions:
Acetaminophen Overdose
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
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Contact Information
Overall Contact
No valid contacts available
Data sourced from ClinicalTrials.gov