A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)
Model scores of the 29,894 trials active now.
Model score 11% 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 10% of the time (1,463 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 2014-02-28, after 2012-02-29 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 2014-02-28. 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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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: coronaryperipheralneuropathyarteryheart
Phrases that lowered it: painvisitand safetyefficacy andsafety of -
Sponsor's past termination rate: 5.5% (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 8.3% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 89 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 310 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers 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
- 2 (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
- 310 (typical: 32)
- Sponsor's past termination rate
- 5.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 89 (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
- 373 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 91 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- capsaicin
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 Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients NCT01478607 · started 2011 · scored riskier than 15% of active trials completed
- Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain NCT02228928 · started 2009 · scored riskier than 16% of active trials completed
- 0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy NCT03113448 · started 2017 · scored riskier than 7% of active trials completed
- Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy NCT00993070 · started 2009 · scored riskier than 11% of active trials completed
- Study With Two Capsaicin Topic Treatments in Diabetic Neuropathy. NCT05029297 · started 2010 · scored riskier than 54% 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.