Moderate Alcohol Consumption (1-3 Drinks Per Day)Phase 4NCT00400621
Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers
A Phase 4 study testing acetaminophen in people with Moderate Alcohol Consumption (1-3 Drinks Per Day), run by Denver Health and Hospital Authority.
Trial summary
The study objective was to evaluate the safety of ten consecutive days of therapeutic acetaminophen dosing in moderate alcohol consumers. The main outcome was liver injury (measured by an increase in mean serum ALT or AST levels). Patients were randomly assigned to 10 days of acetaminophen or placebo. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moderate Alcohol Consumption (1-3 Drinks Per Day)
- What is being tested?
- acetaminophen
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Sep 2003
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects were excluded from the study at baseline if any of the following were evident at baseline:
- Serum acetaminophen level greater than 20 mcg/ml
- Serum AST or ALT levels greater than 50 IU/L
- If female, positive for b-HCG
- Clinically intoxicated, psychiatrically impaired or unable to give informed consent
- Known hypersensitivity to acetaminophen
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- History of ingesting more than four grams of acetaminophen per day for any of the four days preceding study enrollment
- Alcoholic patients as defined by those who consume on average more than three alcoholic beverages daily
- Currently enrolled in another trial or had been enrolled in another trial in the preceding three months
About this study
Official title: Assessment of Hepatic Injury in Subjects Who Consume Moderate Amounts of Alcohol While Being Administered Therapeutic Doses of Acetaminophen:
The study objective was to evaluate the safety of ten consecutive days of therapeutic acetaminophen dosing in moderate alcohol consumers. The main outcome was liver injury (measured by an increase in mean serum ALT or AST levels). Patients were randomly assigned to 10 days of acetaminophen or placebo. Blood tests were measured at baseline, day 4 and day 11 to look for injury. We hypothesized that there would be no difference in liver enzymes between the two groups.
- Being tested
- acetaminophen
- Keywords
- acetaminophen, alcohol, liver injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change in serum ALT between treatment groups
Secondary outcomes (3)
proportion of patients that developed an abnormal ALT
proportion of patients that developed hepatoxicity (ALT>1000 IU>L)
proportion of patients that developed 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 posted17 Nov 2006 (estimated)
- Study startApr 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Alcohol Consumption (1-3 Drinks Per Day)Studies 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
- Enrolment
- 150 participants
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
- Kennon Heard, MD, Principal investigator, Rocky Mountain Poison Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400621
- Sponsor's protocol ID
- COMIRB 02-999
- Status last verified
- Nov 2006
- First submitted
- 16 Nov 2006
- Last updated
- 8 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hepatic Injury in Subjects Who Consume Moderate Amounts of Alcohol While Being Administered Therapeutic Doses of Acetaminophen:
- ClinicalTrials.gov ID
- NCT00400621
- Acronym / sponsor ID
- COMIRB 02-999
- Keywords
- acetaminophen, alcohol, liver injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Study start
- Apr 2003
- Study completion
- Sep 2003
- First posted
- 17 Nov 2006 (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 evaluate the safety of ten consecutive days of therapeutic acetaminophen dosing in moderate alcohol consumers. The main outcome was liver injury (measured by an increase in mean serum ALT or AST levels). Patients were randomly assigned to 10 days of acetaminophen or placebo. Blood tests were measured at baseline, day 4 and day 11 to look for injury. We hypothesized that there would be no difference in liver enzymes between the two groups.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Subjects were excluded from the study at baseline if any of the following were evident at baseline:
- Serum acetaminophen level greater than 20 mcg/ml
- Serum AST or ALT levels greater than 50 IU/L
- If female, positive for b-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 | Drug | – |
Primary outcome
mean change in serum ALT between treatment groups
3 secondary outcomes
proportion of patients that developed an abnormal ALT
proportion of patients that developed hepatoxicity (ALT>1000 IU>L)
proportion of patients that developed 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 8 Jul 2024.
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
Rocky Mountain Poison Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetaminophen in people with Moderate Alcohol Consumption (1-3 Drinks Per Day), run by Denver Health and Hospital Authority.
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 0 inclusion and 9 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
mean change in serum ALT between treatment groups. 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 8 Jul 2024.