Drug Induced Liver InjuryPhase 4Non-DrinkerNCT00616018

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

A Phase 4 study testing acetaminophen in people with Drug Induced Liver Injury, run by Kennon Heard at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Drug Induced Liver Injury
What is being tested?: acetaminophen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Aug 2007to Jan 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

age 21 years or older
provide written informed consent
consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers

Who cannot join

History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment
Currently taking isoniazid
Consumption of any alcoholic beverage during the run-in period
A detectable serum acetaminophen at baseline
Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 50 IU/L at the start of the run-in period or at baseline
Platelet count less than 125,000/cc at baseline

Show all 11Show fewer

Positive pregnancy test at baseline (female participants only)
Currently adheres to a fasting type diet as determined by self report
Currently has anorexia nervosa as determined by self report
Subject appears clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
Known hypersensitivity to acetaminophen

Trial locations and contacts

1 site in 1 country.

United States1 site

Denver Health Rocky Mountain Poison and Drug Center
Denver, Colorado, 80204

Other trials in United States

About this study

Official title: Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days

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.

Conditions: Drug Induced Liver Injury
Being tested: acetaminophen
Keywords: acetaminophen, protein adducts, hepatic function, drug safety, non drinkers
Medical subject headings: Chemical and Drug Induced Liver Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

acetaminophenDrug
Also called Tylenol Extra Strength
4 g/day for 10 consecutive days

Study groups in NCT00616018
Study group	Role	What they receive
A	Experimental	all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study Receives: Drug: acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Alanine Aminotransferase (ALT)
ALT was measured at Day 0, 4, 7, 9, 11, and 14.
Measured: Day 0, 4, 7, 9, 11, and 14.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Jan 2008

First posted14 Feb 2008 (estimated)
Study startAug 2007
Primary completionJan 2008
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Drug Induced Liver InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00616018
Sponsor's protocol ID: COMIRB #06-1187
Other IDs: COMIRB #06-1187
Acronym: Non-Drinker
Status last verified: Jul 2012
First submitted: 4 Feb 2008
Last updated: 12 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Drug Induced Liver Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days
ClinicalTrials.gov ID: NCT00616018
Acronym / sponsor ID: Non-Drinker / COMIRB #06-1187
Conditions: Drug Induced Liver Injury
Keywords: acetaminophen, protein adducts, hepatic function, drug safety, non drinkers
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Kennon HeardUniversity, hospital or other
Collaborators: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Study start: Aug 2007
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 14 Feb 2008 (estimated)
Results: Posted 12 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A	Experimental	Drug: acetaminophenall subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

age 21 years or older
provide written informed consent
consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers

Key exclusion criteria (11 listed)

History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment
Currently taking isoniazid
Consumption of any alcoholic beverage during the run-in period
A detectable serum acetaminophen at baseline
Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 50 IU/L at the start of the run-in period or at baseline

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
acetaminophenAlso: Tylenol Extra Strength4 g/day for 10 consecutive days	Drug	A

Primary outcome

Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts
Time frame: Day 0, 4, 7, 9, 11, and 14.
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.

1 secondary outcome

Alanine Aminotransferase (ALT)
Time frame: Day 0, 4, 7, 9, 11, and 14.

Results and safety

Results posted to the registry on 12 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acetaminophen	27	24

Primary outcome: Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts

Time frame: Day 0, 4, 7, 9, 11, and 14.. Mean (Standard Deviation). Unit: nmol/mL

Measure	Acetaminophen n = 24
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)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from time of first dose of study medication through followup visits.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acetaminophen	0 of 27 (0%)	12 of 27 (44.4%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Drug Induced Liver Injury

Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingEarly Phase 1
Silymarin Versus N-Acetylcysteine as Protective Effect Against Anti-tuberculosis Drugs Induced Liver Injury.
Drug-Induced Acute Liver Injury, Tuberculosis (TB)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruitingPhase 3
Misocholic Tablets for Non-Viral Elevated Liver Enzymes
Alcohol-Related Liver Disease, Drug-Induced Liver Injury

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kennon Heard, MD principal investigator

Denver Health/Rocky Mountain Poison & Drug Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing acetaminophen in people with Drug Induced Liver Injury, run by Kennon Heard at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts (time frame: Day 0, 4, 7, 9, 11, and 14.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00616018.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2012.