A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan

NCT02248480 on ClinicalTrials.gov Phase 3 Eli Lilly and Company (industry) Started 2014-10-31 Completed

Riskier than 9% of active trials

Model scores of the 29,894 trials active now.

Model score 7% 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 12% of the time (114 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 2015-06-30, after 2014-10-31 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 2015-06-30. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: diagnosisuncontrolledcellbaselinescore
Phrases that lowered it: participantskneeeffect ofdrug14 days
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
Minimum age: 40 (lowers risk) · Who can join
Phase: 3 (lowers risk) · Design
Sponsor's past trials: 889 (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 64.1% (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 6.2% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 158 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Maximum age: 79 (raises risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Collaborators: 1 (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 7236 (lowers risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Keywords listed: 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: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 40 (typical: 18)
Maximum age: 79 (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: 889 (typical: 32)
Sponsor's past termination rate: 5.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 158 (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: 46304 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 7236 (typical: 412.5)
Drug's FAERS reports marked serious: 64.1% (typical: 85.6%)
Drug's FAERS reports with a death: 6.2% (typical: 15.9%)

Disease area and drugs

Disease areas: musculoskeletal
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

An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480) NCT02335346 · started 2015 · scored riskier than 7% of active trials completed
A Study of Duloxetine in Patients With Osteoarthritis Knee Pain NCT00945945 · started 2009 · scored riskier than 12% of active trials completed
A Study of Duloxetine in Participants With Chronic Pain Due to Osteoarthritis in China NCT01931475 · started 2013 · scored riskier than 15% of active trials completed
A Mechanism Based Proof of Concept Study of the Effects of Duloxetine in the Treatment of Patients With Osteoarthritic Knee Pain NCT04224584 · started 2020 · scored riskier than 8% of active trials completed
A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis NCT01018680 · started 2009 · scored riskier than 8% 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.