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: August 1, 2014
Last verified: August 2014
Results First Received: April 15, 2014  
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
Condition: Acetaminophen Overdose
Interventions: Drug: Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free)
Drug: Acetadote

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Acetadote Without EDTA

Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]

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

Acetadote

Acetadote [Old formulation containing EDTA]

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.


Participant Flow:   Overall Study
    Acetadote Without EDTA     Acetadote  
STARTED     7     10  
COMPLETED     5     8  
NOT COMPLETED     2     2  
Adverse Event                 2                 1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Acetadote Without EDTA

Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]

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

Acetadote

Acetadote [Old formulation containing EDTA]

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.

Total Total of all reporting groups

Baseline Measures
    Acetadote Without EDTA     Acetadote     Total  
Number of Participants  
[units: participants]
  7     10     17  
Age, Customized  
[units: participants]
     
≤ 18 years     1     0     1  
19-59 years     6     8     14  
≥ 60 years     0     2     2  
Gender  
[units: participants]
     
Female     5     7     12  
Male     2     3     5  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     3     3     6  
Not Hispanic or Latino     4     7     11  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     6     9     15  
More than one race     1     0     1  
Unknown or Not Reported     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     7     10     17  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   To Evaluate the Percentage of Subjects Requiring Continued Therapy   [ Time Frame: 21 hours ]

3.  Secondary:   To Evaluate the Incidence of Clinical Need for Therapy Beyond the Current 21 Hour FDA Approved Dosing Regimen.   [ Time Frame: 42 hours ]

4.  Secondary:   To Evaluate the Incidence of Treatment Emergent Adverse Events   [ Time Frame: 21-42 hours ]

5.  Secondary:   To Evaluate the Incidence of Anaphylactoid Reaction.   [ Time Frame: 1 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Amy Rock, PhD
Organization: Cumberland Pharmaceuticals Inc.
phone: 615-255-0068
e-mail: arock@cumberlandpharma.com


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
Results First Received: April 15, 2014
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration