Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 13% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (273 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 2018-04-30, after 2014-12-08 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 2018-04-30. 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: 21.6% (raises 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: obstructive pulmonarypulmonary diseaseto assessrehabilitationhospitalized
Phrases that lowered it: patients whoevaluate theintranasalto evaluatesafety of -
Minimum age: 76 (lowers risk) · Who can join
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Design: single group (raises risk) · Design
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Drug's FAERS reports marked serious: 80.8% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 60 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 24.7% (raises risk) · Drug's FDA history
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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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Blinding: none (raises risk) · Design
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Phase: 2/3 (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
- 2/3 (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
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 76 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 74 (typical: 32)
- Sponsor's past termination rate
- 21.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 60 (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
- 28202 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5996 (typical: 412.5)
- Drug's FAERS reports marked serious
- 80.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- fentanyl
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
- 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 Dexmedetomidine for Procedural Pain Management in Elderly Adults in Palliative Care NCT03151863 · started 2018 · scored riskier than 17% of active trials terminated
- Intranasal Ketamine Versus Intranasal Fentanyl NCT04414800 · started 2017 · scored riskier than 13% of active trials completed
- Efficacy of Fentanyl to Reduce the Time of Severe Postoperative Pain Relief Compared to Morphine NCT02145975 · started 2014 · scored riskier than 16% of active trials completed
- A Clinical Trial With Intranasal Fentanyl in Cancer Patients With Breakthrough Pain NCT01429051 · started 2011 · scored riskier than 43% 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.