A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (780 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2019-10-05, after 2018-03-12 start.
Reason given by the sponsor: “other”
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 2019-10-05. 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
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cellpatientsubjecttransplantationmonths
Phrases that lowered it: topicalpsoriasisacidasthmaabnormal -
Phase: 2 (raises risk) · Design
-
Primary purpose: prevention (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Number of arms: 4 (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Disease area, dermatology: Yes (raises 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
- 2
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (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
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 1 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, dermatology
- Drugs matched to FDA substances
- squaric acid dibutyl ester
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
- Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis NCT01971385 · started 2013 · scored riskier than 40% of active trials completed
- Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis NCT02965781 · started 2016 · scored riskier than 25% of active trials completed
- Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1) NCT03661541 · started 2017 · scored riskier than 38% 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
- EDTA Eye Drops Compared to Abreva for Herpes Simplex Virus Eruptions NCT04893577 · started 2022 · scored riskier than 65% 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.