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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acetaminophen Overdose
Interventions Drug: Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free)
Drug: Acetadote
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acetadote Without EDTA Acetadote
Hide Arm/Group Description

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 [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.

Period Title: Overall Study
Started 7 10
Completed 5 8
Not Completed 2 2
Reason Not Completed
Adverse Event             2             1
Withdrawal by Subject             0             1
Arm/Group Title Acetadote Without EDTA Acetadote Total
Hide Arm/Group Description

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 [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 of all reporting groups
Overall Number of Baseline Participants 7 10 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
≤ 18 years 1 0 1
19-59 years 6 8 14
≥ 60 years 0 2 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
Female
5
  71.4%
7
  70.0%
12
  70.6%
Male
2
  28.6%
3
  30.0%
5
  29.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
Hispanic or Latino
3
  42.9%
3
  30.0%
6
  35.3%
Not Hispanic or Latino
4
  57.1%
7
  70.0%
11
  64.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
6
  85.7%
9
  90.0%
15
  88.2%
More than one race
1
  14.3%
0
   0.0%
1
   5.9%
Unknown or Not Reported
0
   0.0%
1
  10.0%
1
   5.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 10 participants 17 participants
7 10 17
1.Primary Outcome
Title 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
Hide Description Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
Time Frame 21 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.
Arm/Group Title Acetadote Without EDTA Acetadote
Hide Arm/Group Description:

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 [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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title To Evaluate the Percentage of Subjects Requiring Continued Therapy
Hide Description Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
Time Frame 21 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.
Arm/Group Title Acetadote Without EDTA Acetadote
Hide Arm/Group Description:

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 [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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title To Evaluate the Incidence of Clinical Need for Therapy Beyond the Current 21 Hour FDA Approved Dosing Regimen.
Hide Description Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
Time Frame 42 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.
Arm/Group Title Acetadote Without EDTA Acetadote
Hide Arm/Group Description:

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 [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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title To Evaluate the Incidence of Treatment Emergent Adverse Events
Hide Description [Not Specified]
Time Frame 21-42 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetadote Without EDTA Acetadote
Hide Arm/Group Description:

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 [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.

Overall Number of Participants Analyzed 7 10
Measure Type: Number
Unit of Measure: Number of Events
13 14
5.Secondary Outcome
Title To Evaluate the Incidence of Anaphylactoid Reaction.
Hide Description 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.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetadote Without EDTA Acetadote
Hide Arm/Group Description:

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 [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.

Overall Number of Participants Analyzed 7 10
Measure Type: Number
Unit of Measure: participants
0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetadote Without EDTA Acetadote
Hide Arm/Group Description

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 [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.

All-Cause Mortality
Acetadote Without EDTA Acetadote
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Acetadote Without EDTA Acetadote
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acetadote Without EDTA Acetadote
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/7 (71.43%)      7/10 (70.00%)    
Gastrointestinal disorders     
Nausea *  1/7 (14.29%)  1 1/10 (10.00%)  2
Vomiting *  3/7 (42.86%)  3 3/10 (30.00%)  4
Abdominal Discomfort *  1/7 (14.29%)  1 0/10 (0.00%)  0
General disorders     
Chest Discomfort *  0/7 (0.00%)  0 1/10 (10.00%)  1
Chest Pain *  1/7 (14.29%)  1 0/10 (0.00%)  0
Immune system disorders     
Anaphylactoid Reaction *  0/7 (0.00%)  0 1/10 (10.00%)  1
Investigations     
Blood Potassium Decreased *  0/7 (0.00%)  0 1/10 (10.00%)  1
Blood Magnesium Decreased *  1/7 (14.29%)  1 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Trismus *  1/7 (14.29%)  1 0/10 (0.00%)  0
Nervous system disorders     
Headache *  1/7 (14.29%)  1 0/10 (0.00%)  0
Psychiatric disorders     
Agitation *  1/7 (14.29%)  1 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Wheezing *  0/7 (0.00%)  0 1/10 (10.00%)  1
Cough *  0/7 (0.00%)  0 1/10 (10.00%)  1
Dyspnoea *  2/7 (28.57%)  2 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hyperhidrosis *  0/7 (0.00%)  0 1/10 (10.00%)  1
Flushing *  0/7 (0.00%)  0 1/10 (10.00%)  1
Livedo Reticularis *  0/7 (0.00%)  0 1/10 (10.00%)  1
Vascular disorders     
Hypotension *  1/7 (14.29%)  1 0/10 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Amy Rock, PhD
Organization: Cumberland Pharmaceuticals Inc.
Phone: 615-255-0068
EMail: arock@cumberlandpharma.com
Layout table for additonal information
Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01118663    
Other Study ID Numbers: CPI-NAC-001
First Submitted: May 4, 2010
First Posted: May 7, 2010
Results First Submitted: April 15, 2014
Results First Posted: August 4, 2014
Last Update Posted: August 4, 2014