A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain
Model scores of the 29,894 trials active now.
Model score 29% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 18% of the time (283 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
Terminated on 2011-03-31, after 2009-11-30 start.
Reason given by the sponsor: “enrollment”
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 2011-03-31. 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) (raises risk) · Wording
Phrases that raised it: painmoderate toto severeacuteto determine
Phrases that lowered it: nasalasthmakgimpairedrenal function -
Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Sponsor type: academic or other (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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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 47 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: 13.6% (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 92.1% (raises risk) · Drug's FDA history
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Maximum age: 70 (lowers risk) · Who can join
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Collaborators: 0 (raises risk) · Design
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Keywords listed: 2 (raises 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
- 1/2 (typical: 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
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 42 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 47 (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
- 391 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 96 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- sufentanil
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 Randomized, Double-blind Comparison of Morphine and Sufentanil for Prehospital Traumatic Severe Acute Pain NCT00656773 · started 2008 · scored riskier than 86% of active trials completed
- Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage NCT03872700 · started 2019 · scored riskier than 83% of active trials completed
- Intranasal Ketamine Versus Subcutaneous Ketamine for Treatment of Post-traumatic Acute Pain in the Emergency Department ( INVESCK ) NCT05229055 · started 2023 · scored riskier than 29% of active trials completed
- Intranasal Ketamine Versus Intranasal Fentanyl NCT04414800 · started 2017 · scored riskier than 13% of active trials completed
- Topical Piroxicam vs Soulagel in the Treatment of Acute Extremity Pain After Emergency Department Discharge NCT05054023 · started 2021 · scored riskier than 12% 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.