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Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

This study is currently recruiting participants.
Verified November 2012 by Cumberland Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01118663
First received: May 4, 2010
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Acetaminophen Overdose
 Drug: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]
Drug: Acetadote
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Randomized, Controlled Study to Determine the Efficacy and Safety of a New Formulation of Acetylcysteine Injection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • The incidence of hepatoxicity [ Time Frame: 21 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The percentage of subjects requiring continued therapy [ Time Frame: 21 hours ] [ Designated as safety issue: No ]
  • The incidence of hepatoxicity [ Time Frame: 42 hours ] [ Designated as safety issue: No ]
  • Incidence of treatment emergent adverse events [ Time Frame: 21-42 hours ] [ Designated as safety issue: Yes ]
  • Incidence of anaphylactoid reaction. [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acetadote without EDTA
Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]
 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
Other Name: acetylcysteine
Active Comparator: Acetadote
Acetadote [Old formulation containing EDTA]
 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.
Other Name: acetylcysteine

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118663

Locations
United States, Arizona
Maricopa Medical Center Recruiting
Phoenix, Arizona, United States, 85008
Contact: Mary Murlow, RN     602-344-5166     Mary_Mulrow@dmgaz.org    
Principal Investigator: Dan Quan, DO            
United States, California
Loma Linda University Medical Center Not yet recruiting
Loma Linda, California, United States, 92350
Contact: Sarah Pearl     909-558-4000 ext 81510     SPearl@llu.edu    
Principal Investigator: James W Rhee, MD            
University of California Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Anna Coultas     714-456-8719     acoultas@uci.edu    
Contact: Jerffrey R. Suchard, MD            
Principal Investigator: Jeffrey R Suchard, MD            
UCSD Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Jean Marshall, RN     619-543-6554     jbmarshall@ucsd.edu    
Principal Investigator: Richard Clark, MD            
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Margaret Forbes     303-389-1301     Margaret.Forbes@rmpdc.org    
Principal Investigator: Kennon Heard, MD, PhD            
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80204
Contact: Margaret Forbes     303-389-1301     Margaret.Forbes@rmpdc.org    
Principal Investigator: Richard Dart, MD, PhD            
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Kyle Finnegan     860-550-0868     kfinnegan@harthosp.org    
Principal Investigator: Joao Delgado, MD            
United States, Louisiana
LSU Health Sciences Center - Shreveport Recruiting
Shreveport, Louisiana, United States, 71130
Contact: Kim Hutchinson, RN     318-675-6682     KSmit9@lsuhsc.edu    
Principal Investigator: Thomas Arnold, MD            
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Elnita Rosseto     617-754-2334     erosseto@bidmc.harvard.edu    
Principal Investigator: Michael Ganetsky, MD            
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Virginia Mangolds, N.P.     508-421-1438     Virginia.Mangolds@umassmemorial.org    
Principal Investigator: Sean H Rhyee, MD, MPH            
United States, Michigan
Spectrum Health Butterworth Hospital Terminated
Grand Rapids, Michigan, United States, 44506
United States, North Carolina
East Carolina University Medical Center Recruiting
Greenville, North Carolina, United States, 27834
Contact: Allison Meinhart     252-744-5568     farmera@ecu.edu    
Principal Investigator: William J Meggs, MD, PhD            
United States, Ohio
Toledo Hospital Terminated
Toledo, Ohio, United States, 43606
United States, Texas
Scott & White Medical Center Completed
Temple, Texas, United States, 76508
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals Inc
  More Information

Publications:

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01118663     History of Changes
Other Study ID Numbers: CPI-NAC-001
Study First Received: May 4, 2010
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cumberland Pharmaceuticals:
Acetaminophen overdose; induced hepatotoxicity, liver injury

Additional relevant MeSH terms:
Overdose
Poisoning
Substance-Related Disorders
Acetylcysteine
N-monoacetylcystine
Pentetic Acid
Edetic Acid
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
 Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Chelating Agents
Iron Chelating Agents
Anticoagulants
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013