Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection
A Multi-center, Double-blind, Randomized, Controlled Study to Determine the Efficacy and Safety of a New Formulation of Acetylcysteine Injection
1 other identifier
interventional
17
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2010
Typical duration for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2010
CompletedFirst Posted
Study publicly available on registry
May 7, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
August 4, 2014
CompletedAugust 4, 2014
August 1, 2014
2.2 years
May 4, 2010
April 15, 2014
August 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Incidence of Hepatoxicity as Measured by the Percentage of Subjects With an Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Value > 1000 U/L Versus Those With an ALT and AST < 1000 U/L
Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
21 hours
Secondary Outcomes (4)
To Evaluate the Percentage of Subjects Requiring Continued Therapy
21 hours
To Evaluate the Incidence of Clinical Need for Therapy Beyond the Current 21 Hour FDA Approved Dosing Regimen.
42 hours
To Evaluate the Incidence of Treatment Emergent Adverse Events
21-42 hours
To Evaluate the Incidence of Anaphylactoid Reaction.
1 hour
Study Arms (2)
Acetadote without EDTA
EXPERIMENTALAcetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]
Acetadote
ACTIVE COMPARATORAcetadote \[Old formulation containing EDTA\]
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- \) Any subject requiring treatment with acetylcysteine for acute acetaminophen toxicity
You may not qualify if:
- History of allergy or hypersensitivity to acetylcysteine or any component of Acetadote.
- Exposed to investigational drugs within 30 days before Clinical Trial Material (CTM) administration.
- Pregnant or nursing.
- Less than 12 years of age.
- Have a baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1000 U/L.
- Have a baseline International Normalized. Ratio (INR) \> 2.0
- 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.
- 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.
- 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).
- Refusal to provide written authorization for use and disclosure of protected health information.
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Loma Linda University Medical Center
Loma Linda, California, 92350, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
UCSD Medical Center
San Diego, California, 92103, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
LSU Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, 44506, United States
East Carolina University Medical Center
Greenville, North Carolina, 27834, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
Scott & White Medical Center
Temple, Texas, 76508, United States
Related Publications (4)
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. doi: 10.1111/j.1600-0536.1998.tb05702.x. No abstract available.
PMID: 9536427BACKGROUNDvan 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. doi: 10.1002/mds.870130113.
PMID: 9452326BACKGROUNDKimura M, Kawada A. Contact dermatitis due to trisodium ethylenediaminetetra-acetic acid (EDTA) in a cosmetic lotion. Contact Dermatitis. 1999 Dec;41(6):341. doi: 10.1111/j.1600-0536.1999.tb06184.x. No abstract available.
PMID: 10617216BACKGROUNDMarik PE. Propofol: therapeutic indications and side-effects. Curr Pharm Des. 2004;10(29):3639-49. doi: 10.2174/1381612043382846.
PMID: 15579060BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amy Rock, PhD
- Organization
- Cumberland Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Art Wheeler, MD
Cumberland Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2010
First Posted
May 7, 2010
Study Start
September 1, 2010
Primary Completion
November 1, 2012
Study Completion
May 1, 2013
Last Updated
August 4, 2014
Results First Posted
August 4, 2014
Record last verified: 2014-08