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Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing

NCT02322879 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-09-01

Study results available
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Summary

A purpose of this protocol is to is to compare the metabolites of the toxic bioactivating pathway after acetaminophen alone or acetaminophen followed by Propylene Glycol (PG) and to determine if it prevents the formation of the toxic metabolites of acetaminophen.

Conditions

  • Acetaminophen Toxicity

Interventions

DRUG

First Treatment Period

(duration: 14 days) Subjects will be randomized to receive either of the 2 interventions (4 grams of solid acetaminophen formulation for two weeks vs. 4 grams of solid acetaminophen formulation + 70 mg/kg/day of liquid propylene glycol)

OTHER

Washout

(duration: 14 days) At the end of the First intervention period all participants will enter a washout period.

DRUG

Second Treatment Period

(duration: 14 days) At the end of the washout period, participants will receive the alternative intervention.

Sponsors & Collaborators

Principal Investigators

  • Steven Salhanick, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-08-31
Completion
2016-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02322879 on ClinicalTrials.gov