At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 21 enrolled

Drug / intervention

First Treatment Period +2 moredrug

Likely dose

First Treatment Period 70 mg/kgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02322879

NCT02322879Phase 4Completed

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Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing

Beth Israel Deaconess Medical Center·interventional·Posted Dec 23, 2014·Updated Sep 1, 2017

In Brief

A Phase 4 clinical trial evaluating First Treatment Period, Washout, and 1 other intervention for Acetaminophen Toxicity. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAcetaminophen Toxicity

CountriesUnited States

CollaboratorsHarvard University

Timeline

Phase 4CompletedFinished

20132014201520162017201820192020202120222023202420252026

Enrollment StartMay 2013

First PostedDec 2014

Primary CompletionAug 2016

Study CompletionDec 2016

TodayJul 2026

First PostedDec 23, 2014

Enrollment StartMay 1, 2013

Primary CompletionAug 1, 2016

Study CompletionDec 1, 2016

TodayJul 2, 2026

Enrollment to primary: 3.3 yearsPosted 11.5 years ago

Interventions

First Treatment Perioddrug

(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)

Washoutother

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

Second Treatment Perioddrug

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