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Trial record 60 of 1879 for:    ACETAMINOPHEN

Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days (Non-Drinker)

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ClinicalTrials.gov Identifier: NCT00616018
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : July 12, 2012
Last Update Posted : July 12, 2012
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by (Responsible Party):
Kennon Heard, Denver Health and Hospital Authority

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Drug Induced Liver Injury
Intervention Drug: acetaminophen
Enrollment 35
Recruitment Details Study was conducted from August 2007 through January 2008. Healthy volunteers were recruited through flyers posted in community settings.
Pre-assignment Details 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.
Arm/Group Title Acetaminophen
Hide Arm/Group Description all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Period Title: Overall Study
Started 27
Completed 24
Not Completed 3
Reason Not Completed
Protocol Violation             3
Arm/Group Title Acetaminophen
Hide Arm/Group Description all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
37.3  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
19
  70.4%
Male
8
  29.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts
Hide Description 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.
Time Frame Day 0, 4, 7, 9, 11, and 14.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based upon the 24 subjects who completed all study visits.
Arm/Group Title Acetaminophen
Hide Arm/Group Description:
all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: nmol/mL
Day 0 0.0  (0.0)
Day 4 0.3  (0.1)
Day 7 0.3  (0.2)
Day 9 0.4  (0.2)
Day 11 0.4  (0.2)
Day 14 0.2  (0.1)
2.Secondary Outcome
Title Alanine Aminotransferase (ALT)
Hide Description ALT was measured at Day 0, 4, 7, 9, 11, and 14.
Time Frame Day 0, 4, 7, 9, 11, and 14.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based upon the 24 subjects who completed all study visits.
Arm/Group Title Acetaminophen
Hide Arm/Group Description:
acetaminophen treatment group
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: IU/L
Day 0 24.0  (8.1)
Day 4 25.9  (10.1)
Day 7 41.3  (27.3)
Day 9 41.3  (27.3)
Day 11 41.8  (24.2)
Day 14 36.1  (18.6)
Time Frame Adverse events were collected from time of first dose of study medication through followup visits.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetaminophen
Hide Arm/Group Description all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
All-Cause Mortality
Acetaminophen
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen
Affected / at Risk (%) # Events
Total   0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acetaminophen
Affected / at Risk (%) # Events
Total   12/27 (44.44%)    
Gastrointestinal disorders   
diarrhoea  1  2/27 (7.41%)  2
nausea  1  5/27 (18.52%)  6
General disorders   
fatigue  1  2/27 (7.41%)  2
Nervous system disorders   
headache  1  3/27 (11.11%)  6
migraine  1  2/27 (7.41%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
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: Jody Green
Organization: Denver Health
Phone: 303-389-1246
EMail: jody.green@rmpdc.org
Layout table for additonal information
Responsible Party: Kennon Heard, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT00616018     History of Changes
Other Study ID Numbers: COMIRB #06-1187
COMIRB #06-1187
First Submitted: February 4, 2008
First Posted: February 14, 2008
Results First Submitted: March 3, 2011
Results First Posted: July 12, 2012
Last Update Posted: July 12, 2012