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NCT02322879 · ClinicalTrials.gov registry record · Phase 4
Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing
A Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
NCT02322879: Completed Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
NCT02322879 is a Phase 4 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 21 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02322879, a Phase 4 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
Study 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.
Primary Outcome
Blood tests to monitor Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) were obtained on every visit prior dosing. ALT and AST were analyzed on a Roche Cobas c501 chemistry module at BIDMC. Responders was defined as peak ALT increased 2x baseline (average of first 3 days)
Interventions
- OTHER Washout
- DRUG First Treatment Period
- DRUG Second Treatment Period
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-12 |
| Phase | Phase 4 |
What the finished NCT02322879 record still lists
NCT02322879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Washout is the first listed.
NCT02322879 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02322879 about?
NCT02322879 is a clinical study titled "Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing". 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.
What is the current status of trial NCT02322879?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2013-05. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02322879?
The interventions under investigation include: Washout (OTHER), First Treatment Period (DRUG), Second Treatment Period (DRUG).
Who is sponsoring clinical trial NCT02322879?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02322879's enrollment target sits among peer trials
21 1742nd of 2000 higher than 248 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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