A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain

Model scores of the 29,894 trials active now.

Model score 12% 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 11% of the time (493 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2017-04-03. 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.

• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: diabeticpaindiabeteswomenneuropathic
  Phrases that lowered it: pharmacokineticssafetyformulationsignificantclinically
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Drug's FAERS reports marked serious: 55.6% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Number of arms: 4 (lowers risk) · Design
• Blinding: quadruple (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 8.6% (lowers risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Collaborators: 1 (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.

• A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy NCT01633086 · started 2012 · scored riskier than 28% of active trials completed
• Study of the Safety, Tolerability and Efficacy of V3381 in Patients With Diabetic Peripheral Neuropathic Pain NCT00794430 · started 2008 · scored riskier than 39% of active trials completed
• Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy NCT01496365 · started 2011 · scored riskier than 33% of active trials completed
• Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 for Treating Diabetic Neuropathy NCT04082000 · started 2019 · scored riskier than 26% of active trials terminated
• A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain NCT01579279 · started 2012 · scored riskier than 10% 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.