Phase 4
N=21
Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing
Acetaminophen Toxicity
Bottom Line
View on ClinicalTrials.gov: NCT02322879 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Rise in Plasma Transaminases: Proportion of Responders. — 6; 8 Participants — p=0.59
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- First Treatment Period (Drug); Washout (Other); Second Treatment Period (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rise in Plasma Transaminases: Proportion of Responders. |
6; 8 | 0.59 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02322879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.