Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01118663
First received: May 4, 2010
Last updated: June 21, 2013
Last verified: June 2013

May 4, 2010
June 21, 2013
September 2010
November 2012   (final data collection date for primary outcome measure)
The incidence of hepatoxicity [ Time Frame: 21 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01118663 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acetaminophen Overdose
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
May 2013
November 2012   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01118663
CPI-NAC-001
Yes
Cumberland Pharmaceuticals
Cumberland Pharmaceuticals
Not Provided
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals Inc
Cumberland Pharmaceuticals
June 2013

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