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Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

NCT01118663 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2014-08-04

Study results available
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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.

Conditions

  • Acetaminophen Overdose

Interventions

DRUG

Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free)

Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free) {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours

DRUG

Acetadote

Acetadote \[old formulation\] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.

Sponsors & Collaborators

  • Cumberland Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Art Wheeler, MD · Cumberland Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-11-30
Completion
2013-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01118663 on ClinicalTrials.gov