A Study of the Newly Formulated Tylenol Tablet (Acetaminophen) to the Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants

NCT04230252 on ClinicalTrials.gov Phase 1 Janssen Korea, Ltd., Korea (industry) Started 2020-01-07 Completed

Among the lowest-risk 1% of active trials

Model scores of the 29,894 trials active now.

Model score 2% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2020-03-23, after 2020-01-07 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-03-23. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: diabetesmellitusmalignancycarcinomacell
Phrases that lowered it: healthytabletmmhgclinically significantbioequivalence
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 2.9% (lowers risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Primary purpose: other (lowers risk) · Design
Drug's FAERS reports in the prior 12 months: 57816 (raises risk) · Drug's FDA history
Minimum age: 19 (lowers risk) · Who can join
Drug's FAERS reports with a death: 17.0% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 72.7% (lowers risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Maximum age: not given (raises risk) · Who can join
Sponsor's past trials: 34 (lowers risk) · Sponsor's track record
Disease area, psychiatry: No (lowers risk) · Disease area

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 1 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: other (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 19 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 34 (typical: 32)
Sponsor's past termination rate: 2.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 1 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 389384 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 57816 (typical: 412.5)
Drug's FAERS reports marked serious: 72.7% (typical: 85.6%)
Drug's FAERS reports with a death: 17.0% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: acetaminophen

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

A Study of Newly Formulated Tylenol Tablet (Acetaminophen) and Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants NCT04214691 · started 2019 · scored riskier than 0% of active trials completed
To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Modified-Release Tablets 800 mg NCT05329454 · started 2020 · scored riskier than 0% of active trials completed
Bioequivalence Study to Compare Ibuprofen/ Paracetamol Tablets (200mg Ibuprofen/ 500mg Paracetamol) Versus Nuromol® Tablets (200mg Ibuprofen/ 500mg Paracetamol) NCT06180070 · started 2023 · scored riskier than 0% of active trials completed
To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Controlled-Release Tablets 600 mg in Comparison to the Reference Standard Ibuprofen Tablets in Normal Healthy Volunteers NCT03418805 · started 2017 · scored riskier than 0% of active trials terminated
Acotral® Versus Zetia® Ezetimibe Bioequivalance Study. NCT01597700 · started 2012 · scored riskier than 0% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.