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| ID | Type | Description | Link |
|---|---|---|---|
| COMIRB #06-1187 |
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| Name | Class |
|---|---|
| McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. | INDUSTRY |
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Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetaminophen | Drug | 4 g/day for 10 consecutive days |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts | Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum. | Day 0, 4, 7, 9, 11, and 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Alanine Aminotransferase (ALT) | ALT was measured at Day 0, 4, 7, 9, 11, and 14. | Day 0, 4, 7, 9, 11, and 14. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kennon Heard, MD | Denver Health/Rocky Mountain Poison & Drug Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health Rocky Mountain Poison and Drug Center | Denver | Colorado | 80204 | United States |
Thirty-five subjects were consented for the study. Of these, eight were excluded (six did not meet inclusion criteria and two refused to participate). The 27 eligible subjects were assigned to the treatment arm to receive 4 grams of acetaminophen per day, for 10 consecutive days.
Study was conducted from August 2007 through January 2008. Healthy volunteers were recruited through flyers posted in community settings.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen | all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen | all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts | Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum. | Analysis is based upon the 24 subjects who completed all study visits. | Posted | Mean | Standard Deviation | nmol/mL | Day 0, 4, 7, 9, 11, and 14. |
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Adverse events were collected from time of first dose of study medication through followup visits.
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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 | Acetaminophen | all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
One limitation is that this study did not include a placebo group. The study was limited to healthy volunteers. The ingestion of each dose and use of other medications was self-reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jody Green | Denver Health | 303-389-1246 | jody.green@rmpdc.org |
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| ID | Term |
|---|---|
| D056486 | Chemical and Drug Induced Liver Injury |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Alanine Aminotransferase (ALT) | ALT was measured at Day 0, 4, 7, 9, 11, and 14. | Analysis is based upon the 24 subjects who completed all study visits. | Posted | Mean | Standard Deviation | IU/L | Day 0, 4, 7, 9, 11, and 14. |
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| 0 |
| 27 |
| 12 |
| 27 |
| nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| fatigue | General disorders | MedDRA | Systematic Assessment |
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| headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| migraine | Nervous system disorders | MedDRA | Systematic Assessment |
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| D011041 | Poisoning |
| Aniline Compounds |
| D000588 | Amines |
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| Day 9 |
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| Day 11 |
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| Day 14 |
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