Safety and Pharmacokinetics of Kovacaine Nasal Spray in Pediatric Subjects
Model scores of the 29,894 trials active now.
Model score 3% 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 13% of the time (1,304 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 2013-10-31, after 2013-09-30 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 2013-10-31. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: patientdefineduncontrolledthe investigatorrecurrent
Phrases that lowered it: healthypharmacokineticssubjectsnasalable to -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Phase: 2 (raises risk) · Design
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Collaborators: 3 (lowers risk) · Design
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Sponsor's past termination rate: 10% (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports with a death: 15.4% (lowers risk) · Drug's FDA history
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Maximum age: 17 (raises risk) · Who can join
-
Minimum age: 3 (lowers risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 3 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 3 (typical: 18)
- Maximum age
- 17 (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
- 10 (typical: 32)
- Sponsor's past termination rate
- 10% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 6927 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1455 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- oxymetazoline, tetracaine
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
- Dose-Escalation Safety and Pharmacokinetic Study of K305 NCT01304316 · started 2010 · scored riskier than 4% of active trials completed
- Safety and Pharmacokinetics of Kovacaine Nasal Spray (24 Hour Blood Collection) NCT01807624 · started 2013 · scored riskier than 3% of active trials completed
- Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects NCT01701505 · started 2012 · scored riskier than 4% of active trials completed
- Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Pediatric Patients NCT01844830 · started 2013 · scored riskier than 9% of active trials completed
- Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth NCT01660893 · started 2012 · scored riskier than 5% of active trials terminated
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.