A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 2% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-07-02, after 2021-11-23 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 2024-07-02. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: applymonthsrandomizationprotocolsymptoms
Phrases that lowered it: participantmgtabletparticipantsoral -
Phase: 3 (lowers risk) · Design
-
Sponsor's past trials: 945 (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 13.5% (lowers risk) · Drug's FDA history
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Sponsor's past termination rate: 7.7% (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 71 (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports marked serious: 75.8% (lowers risk) · Drug's FDA history
-
Disease area, dermatology: Yes (raises risk) · Disease area
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Disease area, neurology: 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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (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
- 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
- 945 (typical: 32)
- Sponsor's past termination rate
- 7.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 71 (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
- 98231 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 14933 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.5% (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
- EDTA Eye Drops Compared to Abreva for Herpes Simplex Virus Eruptions NCT04893577 · started 2022 · scored riskier than 65% of active trials completed
- Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes NCT02871492 · started 2016 · scored riskier than 11% 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
- Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Treatment of Cold Sores NCT01985321 · started 2013 · scored riskier than 32% of active trials completed
- Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for Episodic Treatment of Cold Sores NCT03192306 · started 2017 · scored riskier than 23% 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.