Acetaminophen-Protein Adduct Resolution | NCT01021410

Studies
Acetaminophen-Protein Adduct Resolution

NCT01021410

Sponsor

Denver Health and Hospital Authority

Status

Completed

Last Update Posted

Aug 8, 2012Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Acetaminophen-protein Adduct Formation

Interventions

Not provided

Countries

United States

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

Aug 2012

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

Nov 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Nov 25, 2009

First Submission Date that Met QC Criteria

Nov 27, 2009

First Posted Date

Nov 30, 2009Estimated

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

Aug 7, 2012

Last Update Posted Date

Aug 8, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kennon Heard, Fellowship Director, Denver Health and Hospital AuthorityPrincipal Investigator

Lead Sponsor

Denver Health and Hospital AuthorityOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to better understand the pharmacokinetics of acetaminophen and further clinical interpretations of laboratory results that confirm the presence of acetaminophen-cys adducts. This study will determine how long adducts persist in serum after a therapeutic course of acetaminophen as taken in a previous study (COMIRB 06-1265). Subjects will be asked to complete three study visits, each three days apart, following termination of COMIRB 06-1265. Each study visit will include collection of blood samples for batch testing of aminotransferase, serum acetaminophen and protein adducts. No interventions are planned.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acetaminophen Group		Subjects who completed COMIRB 06-1265 and were assigned to the acetaminophen treatment group for that study.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome of the proposed study is to determine the proportion of subjects with acetaminophen-cys adduct concentrations above the limit of quantification at day 6 after stopping maximum acetaminophen dosing.		Day 6

Secondary Outcomes

Measure	Description	Time Frame
The secondary outcomes of the proposed study are the serum acetaminophen-cys adduct concentrations at 3, 6, 9 days after stopping maximum acetaminophen dosing of the COMIRB 06-1265 study.		Days 3, 6, 9

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any subject randomized to the acetaminophen arm of COMIRB 06-1265 and meets completion criteria

Exclusion Criteria:

Subjects who enter the extended dosing period in protocol 06-1265.
Subjects who were randomized to placebo.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All subjects who have met completion criteria for COMIRB 06-1265 and were assigned to the acetaminophen treatment group for that study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kennon Heard, MD	Denver Health and Hospital Authority	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Hospital CTRC		Aurora	Colorado	80045	United States
Denver Health and Hospital Authority