CompletedPhase 4

Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing

United States21 participantsStarted 2013-05

Plain-language 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.

Who can participate

Age range20 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy volunteers ages 20-40 * Patients not taking any chronic medications Exclusion Criteria: * Any history of liver disease * Frequent alcohol use (2 or more drinks more than 4 times per week) * Pregnant women * Chronic medical condition requiring daily pharmacotherapy or the use of any daily prescription medications. * Unable to provide informed consent

What they're measuring

Rise in Plasma Transaminases: Proportion of Responders.

Timeframe: Daily during the treatment periods (D1-D14 and D29 to 42)

Trial details

NCT IDNCT02322879

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08

Results submitted2017-03-29

View on ClinicalTrials.gov More Acetaminophen Toxicity trials