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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetadote without EDTA | Experimental | Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] |
|
| Acetadote | Active Comparator | Acetadote [Old formulation containing EDTA] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis. | 21 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Percentage of Subjects Requiring Continued Therapy | Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis. | 21 hours |
| To Evaluate the Incidence of Clinical Need for Therapy Beyond the Current 21 Hour FDA Approved Dosing Regimen. |
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Inclusion Criteria:
1) Any subject requiring treatment with acetylcysteine for acute acetaminophen toxicity
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Art Wheeler, MD | Cumberland Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Medical Center | Phoenix | Arizona | 85008 | United States | ||
| Loma Linda University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9536427 | Background | Bhushan M, Beck MH. Allergic contact dermatitis from disodium ethylenediamine tetra-acetic acid (EDTA) in a local anaesthetic. Contact Dermatitis. 1998 Mar;38(3):183. doi: 10.1111/j.1600-0536.1998.tb05702.x. No abstract available. | |
| 9452326 | Background | van Laar T, van Hilten B, Neef C, Rutgers AW, Pavel S, Bruijn JA. The role of EDTA in provoking allergic reactions to subcutaneous infusion of apomorphine in patients with Parkinson's disease: a histologic study. Mov Disord. 1998 Jan;13(1):52-5. doi: 10.1002/mds.870130113. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Acetadote | Drug | 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. |
|
|
Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis. |
| 42 hours |
| To Evaluate the Incidence of Treatment Emergent Adverse Events | 21-42 hours |
| To Evaluate the Incidence of Anaphylactoid Reaction. | 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. | 1 hour |
| Loma Linda |
| California |
| 92350 |
| United States |
| University of California Irvine Medical Center | Orange | California | 92868 | United States |
| UCSD Medical Center | San Diego | California | 92103 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| LSU Health Sciences Center - Shreveport | Shreveport | Louisiana | 71130 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Spectrum Health Butterworth Hospital | Grand Rapids | Michigan | 44506 | United States |
| East Carolina University Medical Center | Greenville | North Carolina | 27834 | United States |
| Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Scott & White Medical Center | Temple | Texas | 76508 | United States |
| 10617216 | Background | Kimura M, Kawada A. Contact dermatitis due to trisodium ethylenediaminetetra-acetic acid (EDTA) in a cosmetic lotion. Contact Dermatitis. 1999 Dec;41(6):341. doi: 10.1111/j.1600-0536.1999.tb06184.x. No abstract available. |
| 15579060 | Background | Marik PE. Propofol: therapeutic indications and side-effects. Curr Pharm Des. 2004;10(29):3639-49. doi: 10.2174/1381612043382846. |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis. | Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis. | Posted | 21 hours |
|
| ||||||||||||||||||||||
| Secondary | To Evaluate the Percentage of Subjects Requiring Continued Therapy | Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis. | Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis. | Posted | 21 hours |
|
| ||||||||||||||||||||||
| Secondary | To Evaluate the Incidence of Clinical Need for Therapy Beyond the Current 21 Hour FDA Approved Dosing Regimen. | Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis. | Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis. | Posted | 42 hours |
|
| ||||||||||||||||||||||
| Secondary | To Evaluate the Incidence of Treatment Emergent Adverse Events | Posted | Number | Number of Events | 21-42 hours |
|
| ||||||||||||||||||||||
| Secondary | To Evaluate the Incidence of Anaphylactoid Reaction. | 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. | Posted | Number | participants | 1 hour |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 7 | 5 | 7 | ||
| EG001 | 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. | 0 | 10 | 7 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Flushing | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Blood Potassium Decreased | Investigations | Non-systematic Assessment |
| ||
| Livedo Reticularis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Chest Discomfort | General disorders | Non-systematic Assessment |
| ||
| Anaphylactoid Reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Chest Pain | General disorders | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Blood Magnesium Decreased | Investigations | Non-systematic Assessment |
| ||
| Trismus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Abdominal Discomfort | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Rock, PhD | Cumberland Pharmaceuticals Inc. | 615-255-0068 | arock@cumberlandpharma.com |
| ID | Term |
|---|---|
| D004492 | Edetic Acid |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Title | Measurements |
|---|---|
|
| ≥ 60 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|