Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis

NCT02265913 on ClinicalTrials.gov Phase 3 Padagis LLC (industry) Started 2014-10-06 Completed

Riskier than 8% of active trials

Model scores of the 29,894 trials active now.

Model score 7% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (876 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Completed on 2017-11-21, after 2014-10-06 start.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

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 2017-11-21. 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: recurrenttherapyantiviraldiseasenon
Phrases that lowered it: subjectsdrugscreeningfemalesstudy medication
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Phase: 3 (lowers risk) · Design
Drug's FAERS reports with a death: 21.9% (raises risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports before start: 18360 (raises risk) · Drug's FDA history
Maximum age: not given (lowers risk) · Who can join
Number of arms: 3 (lowers risk) · Design
Disease area, infectious disease: Yes (lowers risk) · Disease area
Blinding: double (raises risk) · Design
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Minimum age: 12 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 88.2% (lowers risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Drug's FAERS reports in the prior 12 months: 3120 (raises risk) · Drug's FDA history

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: 3 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: 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: 12 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 12 (typical: 32)
Sponsor's past termination rate: 0% (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: 18360 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3120 (typical: 412.5)
Drug's FAERS reports marked serious: 88.2% (typical: 85.6%)
Drug's FAERS reports with a death: 21.9% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, dermatology
Drugs matched to FDA substances: acyclovir

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

Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes NCT02871492 · started 2016 · scored riskier than 11% of active trials completed
Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus Eruptions NCT06558838 · started 2024 · scored riskier than 24% of active trials completed
Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores NCT02483182 · started 2015 · scored riskier than 8% of active trials completed
EDTA Eye Drops Compared to Abreva for Herpes Simplex Virus Eruptions NCT04893577 · started 2022 · scored riskier than 65% of active trials completed
A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis NCT02207881 · started 2014 · scored riskier than 14% 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.