drugset / Trial / NCT01118663

Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

NCT01118663

Phase 3 Terminated 17 enrolled Cumberland Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-09
Primary completion
2012-11
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 100 mg/kg

Indications