Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

PHASE3TerminatedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

November 30, 2012

Study Completion Date

May 31, 2013

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.

Trial Locations (14)

27834

East Carolina University Medical Center, Greenville

43606

Toledo Hospital, Toledo

44506

Spectrum Health Butterworth Hospital, Grand Rapids

71130

LSU Health Sciences Center - Shreveport, Shreveport

76508

Scott & White Medical Center, Temple

80045

University of Colorado Hospital, Aurora

80204

Denver Health and Hospital Authority, Denver

85008

Maricopa Medical Center, Phoenix

92103

UCSD Medical Center, San Diego

92350

Loma Linda University Medical Center, Loma Linda

92868

University of California Irvine Medical Center, Orange

06102

Hartford Hospital, Hartford

02215

Beth Israel Deaconess Medical Center, Boston

01655

UMass Memorial Medical Center, Worcester

Sponsors
All Listed Sponsors
lead

Cumberland Pharmaceuticals

INDUSTRY