Trial Outcomes & Findings for Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days (NCT NCT00616018)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

Day 0, 4, 7, 9, 11, and 14.

Results posted on

2012-07-12

Participant Flow

Study was conducted from August 2007 through January 2008. Healthy volunteers were recruited through flyers posted in community settings.

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.

Participant milestones

Participant milestones
Measure	Acetaminophen all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Overall Study STARTED	27
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Acetaminophen all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Overall Study Protocol Violation	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetaminophen n=27 Participants all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	37.3 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0, 4, 7, 9, 11, and 14.

Population: Analysis is based upon the 24 subjects who completed all study visits.

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.

Outcome measures

Outcome measures
Measure	Acetaminophen n=24 Participants all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts Day 9	0.4 nmol/mL Standard Deviation 0.2
Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts Day 11	0.4 nmol/mL Standard Deviation 0.2
Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts Day 14	0.2 nmol/mL Standard Deviation 0.1
Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts Day 0	0.0 nmol/mL Standard Deviation 0.0
Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts Day 4	0.3 nmol/mL Standard Deviation 0.1
Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts Day 7	0.3 nmol/mL Standard Deviation 0.2

SECONDARY outcome

Timeframe: Day 0, 4, 7, 9, 11, and 14.

Population: Analysis is based upon the 24 subjects who completed all study visits.

ALT was measured at Day 0, 4, 7, 9, 11, and 14.

Outcome measures

Outcome measures
Measure	Acetaminophen n=24 Participants all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Alanine Aminotransferase (ALT) Day 0	24.0 IU/L Standard Deviation 8.1
Alanine Aminotransferase (ALT) Day 4	25.9 IU/L Standard Deviation 10.1
Alanine Aminotransferase (ALT) Day 7	41.3 IU/L Standard Deviation 27.3
Alanine Aminotransferase (ALT) Day 9	41.3 IU/L Standard Deviation 27.3
Alanine Aminotransferase (ALT) Day 11	41.8 IU/L Standard Deviation 24.2
Alanine Aminotransferase (ALT) Day 14	36.1 IU/L Standard Deviation 18.6

Adverse Events

Acetaminophen

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Acetaminophen n=27 participants at risk all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Gastrointestinal disorders diarrhoea	7.4% 2/27 • Number of events 2 • Adverse events were collected from time of first dose of study medication through followup visits.
Gastrointestinal disorders nausea	18.5% 5/27 • Number of events 6 • Adverse events were collected from time of first dose of study medication through followup visits.
General disorders fatigue	7.4% 2/27 • Number of events 2 • Adverse events were collected from time of first dose of study medication through followup visits.
Nervous system disorders headache	11.1% 3/27 • Number of events 6 • Adverse events were collected from time of first dose of study medication through followup visits.
Nervous system disorders migraine	7.4% 2/27 • Number of events 2 • Adverse events were collected from time of first dose of study medication through followup visits.

Additional Information

Jody Green

Denver Health

Phone: 303-389-1246

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place