Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

Condition(s) targeted: Acetaminophen Overdose

Intervention: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] (Drug); Acetadote (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Cumberland Pharmaceuticals

Official(s) and/or principal investigator(s):
Art Wheeler, MD, Study Director, Affiliation: Cumberland Pharmaceuticals Inc

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.

Official title: A Multi-center, Double-blind, Randomized, Controlled Study to Determine the Efficacy and Safety of a New Formulation of Acetylcysteine Injection

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

Primary outcome: The incidence of hepatoxicity

Secondary outcome:

The percentage of subjects requiring continued therapy

The incidence of hepatoxicity

Incidence of treatment emergent adverse events

Incidence of anaphylactoid reaction.

Detailed 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.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1) Any subject requiring treatment with acetylcysteine for acute acetaminophen toxicity

Exclusion Criteria:

1. History of allergy or hypersensitivity to acetylcysteine or any component of Acetadote.

2. Exposed to investigational drugs within 30 days before Clinical Trial Material (CTM) administration.

3. Pregnant or nursing.

4. Less than 12 years of age.

5. Have a baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1000 U/L.

6. Have a baseline International Normalized. Ratio (INR) > 2. 0

7. Be on dialysis or having existing renal injury such that the volume of the study drug administration would render the patient unsuitable for the study, in the opinion of the investigator.

8. Have congestive heart failure such that the volume of the study drug administration would render the patient unsuitable for the study, in the opinion of the investigator.

9. Inability to understand the requirements of the study. Subjects must be willing to provide written informed consent or consent of parent/legal guardian (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions. (If the subject is incapacitated, informed consent will be sought from a legally acceptable representative).

10. Refusal to provide written authorization for use and disclosure of protected health information.

11. Be otherwise unsuitable for the study, in the opinion of the Investigator.

Maricopa Medical Center, Phoenix, Arizona 85008, United States; Recruiting
Mary Murlow, RN, Phone: 602-344-5166, Email: Mary_Mulrow@dmgaz.org
Dan Quan, DO, Principal Investigator

Loma Linda University Medical Center, Loma Linda, California 92350, United States; Not yet recruiting
Sarah Pearl, Phone: 909-558-4000, Ext: 81510, Email: SPearl@llu.edu
James W Rhee, MD, Principal Investigator

University of California Irvine Medical Center, Orange, California 92868, United States; Recruiting
Anna Coultas, Phone: 714-456-8719, Email: acoultas@uci.edu
Jerffrey R. Suchard, MD
Jeffrey R Suchard, MD, Principal Investigator

UCSD Medical Center, San Diego, California 92103, United States; Recruiting
Jean Marshall, RN, Phone: 619-543-6554, Email: jbmarshall@ucsd.edu
Richard Clark, MD, Principal Investigator

University of Colorado Hospital, Aurora, Colorado 80045, United States; Recruiting
Margaret Forbes, Phone: 303-389-1301, Email: Margaret.Forbes@rmpdc.org
Kennon Heard, MD, PhD, Principal Investigator

Denver Health and Hospital Authority, Denver, Colorado 80204, United States; Recruiting
Margaret Forbes, Phone: 303-389-1301, Email: Margaret.Forbes@rmpdc.org
Richard Dart, MD, PhD, Principal Investigator

Hartford Hospital, Hartford, Connecticut 06102, United States; Recruiting
Kyle Finnegan, Phone: 860-550-0868, Email: kfinnegan@harthosp.org
Joao Delgado, MD, Principal Investigator

LSU Health Sciences Center - Shreveport, Shreveport, Louisiana 71130, United States; Recruiting
Kim Hutchinson, RN, Phone: 318-675-6682, Email: KSmit9@lsuhsc.edu
Thomas Arnold, MD, Principal Investigator

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Elnita Rosseto, Phone: 617-754-2334, Email: erosseto@bidmc.harvard.edu
Michael Ganetsky, MD, Principal Investigator

UMass Memorial Medical Center, Worcester, Massachusetts 01655, United States; Recruiting
Virginia Mangolds, N.P., Phone: 508-421-1438, Email: Virginia.Mangolds@umassmemorial.org
Sean H Rhyee, MD, MPH, Principal Investigator

Spectrum Health Butterworth Hospital, Grand Rapids, Michigan 44506, United States; Terminated

East Carolina University Medical Center, Greenville, North Carolina 27834, United States; Recruiting
Allison Meinhart, Phone: 252-744-5568, Email: farmera@ecu.edu
William J Meggs, MD, PhD, Principal Investigator

Toledo Hospital, Toledo, Ohio 43606, United States; Terminated

Scott & White Medical Center, Temple, Texas 76508, United States; Completed

Related publications:

Bhushan M, Beck MH. Allergic contact dermatitis from disodium ethylenediamine tetra-acetic acid (EDTA) in a local anaesthetic. Contact Dermatitis. 1998 Mar;38(3):183. No abstract available.

van Laar T, van Hilten B, Neef C, Rutgers AW, Pavel S, Bruijn JA. The role of EDTA in provoking allergic reactions to subcutaneous infusion of apomorphine in patients with Parkinson's disease: a histologic study. Mov Disord. 1998 Jan;13(1):52-5.

Kimura M, Kawada A. Contact dermatitis due to trisodium ethylenediaminetetra-acetic acid (EDTA) in a cosmetic lotion. Contact Dermatitis. 1999 Dec;41(6):341. No abstract available.

Marik PE. Propofol: therapeutic indications and side-effects. Curr Pharm Des. 2004;10(29):3639-49. Review.

Starting date: September 2010
Last updated: November 29, 2012