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Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01118663
Recruitment Status : Terminated
First Posted : May 7, 2010
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE May 4, 2010
First Posted Date  ICMJE May 7, 2010
Results First Submitted Date  ICMJE April 15, 2014
Results First Posted Date  ICMJE August 4, 2014
Last Update Posted Date August 4, 2014
Study Start Date  ICMJE September 2010
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2014)
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 [ Time Frame: 21 hours ]
Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2010)
The incidence of hepatoxicity [ Time Frame: 21 hours ]
Change History Complete list of historical versions of study NCT01118663 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2014)
  • To Evaluate the Percentage of Subjects Requiring Continued Therapy [ Time Frame: 21 hours ]
    Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
  • To Evaluate the Incidence of Clinical Need for Therapy Beyond the Current 21 Hour FDA Approved Dosing Regimen. [ Time Frame: 42 hours ]
    Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
  • To Evaluate the Incidence of Treatment Emergent Adverse Events [ Time Frame: 21-42 hours ]
  • To Evaluate the Incidence of Anaphylactoid Reaction. [ Time Frame: 1 hour ]
    Data analysis was conducted on the subjects enrolled in the study prior to study termination. Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2010)
  • The percentage of subjects requiring continued therapy [ Time Frame: 21 hours ]
  • The incidence of hepatoxicity [ Time Frame: 42 hours ]
  • Incidence of treatment emergent adverse events [ Time Frame: 21-42 hours ]
  • Incidence of anaphylactoid reaction. [ Time Frame: 1 hour ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection
Official Title  ICMJE A Multi-center, Double-blind, Randomized, Controlled Study to Determine the Efficacy and Safety of a New Formulation of Acetylcysteine Injection
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acetaminophen Overdose
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Acetadote without EDTA
    Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]
    Intervention: Drug: Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free)
  • Active Comparator: Acetadote
    Acetadote [Old formulation containing EDTA]
    Intervention: Drug: Acetadote
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 21, 2013)
17
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2010)
200
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01118663
Other Study ID Numbers  ICMJE CPI-NAC-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cumberland Pharmaceuticals
Study Sponsor  ICMJE Cumberland Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals, Inc.
PRS Account Cumberland Pharmaceuticals
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP