A Study in Participants With Diabetic Peripheral Neuropathic Pain in China

NCT01179672 on ClinicalTrials.gov Phase 3 Eli Lilly and Company (industry) Started 2011-04-30 Completed

Riskier than 20% of active trials

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (734 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 2013-08-31, after 2011-04-30 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 2013-08-31. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 5.1% (lowers risk) · Sponsor's track record
Disease area, neurology: Yes (raises risk) · Disease area
Phase: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 61.3% (lowers risk) · Drug's FDA history
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: placeboor equalequal todiagnosisiv
Phrases that lowered it: ulnuppernormalscreeningparticipant
Drug's FAERS reports with a death: 6.2% (lowers risk) · Drug's FDA history
Sponsor's past trials: 545 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 194 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports before start: 24067 (raises risk) · Drug's FDA history
Maximum age: not given (lowers risk) · Who can join
Collaborators: 0 (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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 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: 545 (typical: 32)
Sponsor's past termination rate: 5.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 194 (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: 24067 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5299 (typical: 412.5)
Drug's FAERS reports marked serious: 61.3% (typical: 85.6%)
Drug's FAERS reports with a death: 6.2% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology, endocrine
Drugs matched to FDA substances: duloxetine

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 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants With Diabetic Neuropathic Pain NCT04641273 · started 2021 · scored riskier than 29% of active trials terminated
A Study in Painful Diabetic Neuropathy NCT01089556 · started 2010 · scored riskier than 23% of active trials completed
Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy NCT03219320 · started 2017 · scored riskier than 34% of active trials completed
Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain NCT05177094 · started 2022 · scored riskier than 51% of active trials completed
A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain NCT06074562 · started 2023 · scored riskier than 64% 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.