Alcohol Related DisordersPhase 4NCT00427206
Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing
A Phase 4 study testing acetaminophen (4g/day) in people with Alcohol Related Disorders, run by Denver Health and Hospital Authority at 2 sites in 2 countries.
Trial summary
The study objective was to determine if liver injury develops in alcoholic patients during or following 5 days of therapeutic acetaminophen dosing. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4g/day) or placebo for 5 consecutive days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Related Disorders
- What is being tested?
- acetaminophen (4g/day)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2004to Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- admitted to participating detox facility with a positive BAL at the time of admittance
- signed a written informed consent
Who cannot join
- serum acetaminophen level greater than 20 mcg/ml
- serum AST or ALT levels greater than 200 IU/L
- INR greater than 1.5
- if female, positive for beta-subunit of chorionic gonadotropin (beta-HCG)
- clinically intoxicated, psychiatrically impaired or unable to give informed consent
- known hypersensitivity to acetaminophen
- history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment
- currently enrolled in another trial or had been enrolled in another trial in the preceding three months.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics
The study objective was to determine if liver injury develops in alcoholic patients during or following 5 days of therapeutic acetaminophen dosing. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4g/day) or placebo for 5 consecutive days. All subjects were monitored an additional two days following the dosing period. The primary measures were aminotransferase measures taken at baseline and Days 2, 4, 6 and 7. We hypothesized that there would be no difference in aminotransferase means between the groups at any study period.
- Conditions
- Alcohol Related Disorders
- Being tested
- acetaminophen (4g/day), placebo
- Keywords
- acetaminophen, alcohol, liver injury
- Medical subject headings
- Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophen (4g/day)Drug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | acetaminophen 4 g/day Receives: Drug: acetaminophen (4g/day) |
| 2 | Placebo comparator | placebo undistinguishable from active drug Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
group mean aminotransferase measures
mean change in aminotransferase measures between study groups
Secondary outcomes (3)
proportion of subjects that develop an aminotransferase level greater than the upper limit of reference range
proportion of subjects that develop hepatotoxicity (ALT>1000 IU/L)
proportion of subjects that develop drug induced liver injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2007 (estimated)
- Study startNov 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Related DisordersStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Investigators
- Richard C Dart, MD, PhD, Principal investigator, Denver Health/Rocky Mountain Poison & Drug CenterBruna Brands, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427206
- Sponsor's protocol ID
- COMIRB #04-0486
- Status last verified
- Feb 2009
- First submitted
- 24 Jan 2007
- Last updated
- 9 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics
- ClinicalTrials.gov ID
- NCT00427206
- Acronym / sponsor ID
- COMIRB #04-0486
- Conditions
- Alcohol Related Disorders
- Keywords
- acetaminophen, alcohol, liver injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Study start
- Nov 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 26 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective was to determine if liver injury develops in alcoholic patients during or following 5 days of therapeutic acetaminophen dosing. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4g/day) or placebo for 5 consecutive days. All subjects were monitored an additional two days following the dosing period. The primary measures were aminotransferase measures taken at baseline and Days 2, 4, 6 and 7. We hypothesized that there would be no difference in aminotransferase means between the groups at any study period.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: acetaminophen (4g/day)acetaminophen 4 g/day |
| 2 | Placebo comparator | Drug: placeboplacebo undistinguishable from active drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- admitted to participating detox facility with a positive BAL at the time of admittance
- signed a written informed consent
Key exclusion criteria (8 listed)
- serum acetaminophen level greater than 20 mcg/ml
- serum AST or ALT levels greater than 200 IU/L
- INR greater than 1.5
- if female, positive for beta-subunit of chorionic gonadotropin (beta-HCG)
- clinically intoxicated, psychiatrically impaired or unable to give informed consent
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 |
|---|---|---|
| acetaminophen (4g/day) | Drug | 1 |
| placebo | Drug | 2 |
Primary outcome
group mean aminotransferase measures
mean change in aminotransferase measures between study groups
3 secondary outcomes
proportion of subjects that develop an aminotransferase level greater than the upper limit of reference range
proportion of subjects that develop hepatotoxicity (ALT>1000 IU/L)
proportion of subjects that develop drug induced liver injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
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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.
Richard C Dart, MD, PhD principal investigator
Denver Health/Rocky Mountain Poison & Drug Center
Bruna Brands, PhD principal investigator
Centre for Addiction and Mental Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetaminophen (4g/day) in people with Alcohol Related Disorders, run by Denver Health and Hospital Authority at 2 sites in 2 countries.
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 8 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 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
group mean aminotransferase measures. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2009.