Effects of Therapeutic Doses of Acetaminophen in Moderate... | NCT00400621

Studies
Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers

NCT00400621

Sponsor

Denver Health and Hospital Authority

Status

Completed

Last Update Posted

Jul 8, 2024Actual

Enrollment

150

Phase

Phase 4

Conditions

Moderate Alcohol Consumption (1-3 Drinks Per Day)

Interventions

acetaminophen

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Sep 2003

First Submitted Date

Nov 16, 2006

First Submission Date that Met QC Criteria

Nov 16, 2006

First Posted Date

Nov 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2024

Last Update Posted Date

Jul 8, 2024Actual

Name	Class
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	INDUSTRY

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
acetaminophen	Drug

Measure	Description	Time Frame
mean change in serum ALT between treatment groups

Eligibility Module

Eligibility Criteria

Inclusion criteria Adult volunteers of age 21 years or older, regardless of ethnicity or gender, who provided written consent and met all three of the following criteria of a moderate alcohol consumer:

Average baseline ethanol consumption of at least one alcoholic beverage per day before enrollment for the past two months. The estimate of ethanol intake was based on the average intake over seven days. For example, a person who ingested no alcohol on Sunday, Monday, Tuesday or Wednesday, two drinks on Thursday and four drinks on Friday and Saturday would be calculated as 10 drinks/7days = 1.4 drinks/day. The average alcoholic beverage contains 15 grams of alcohol(9).
Average baseline ethanol consumption of no more than three alcoholic beverages (> 45 grams of alcohol) per day, calculated as a weekly average over the preceding two months.
At least one alcohol-containing drink within the last 48 hours

Exclusion Criteria

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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Measure	Description	Time Frame
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