A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 1% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2026-05-08, after 2021-02-22 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2026-05-08. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: randomizationsubjectearlyprior28 days
Phrases that lowered it: and safetyefficacy andsafety offoodday -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
-
Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 21.3% (raises risk) · Drug's FDA history
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Maximum age: 17 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 96.7% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Blinding: double (raises risk) · Design
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Number of arms: 2 (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
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 9 (typical: 18)
- Maximum age
- 17 (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
- 15 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 61 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- acotiamide
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
- Phase III, Long-term, Open-label Safety Study of Z-338 NCT01973790 · started 2014 · scored riskier than 50% of active trials completed
- To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia NCT00761358 · started 2008 · scored riskier than 20% of active trials completed
- A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia NCT00764374 · started 2008 · scored riskier than 18% of active trials completed
- A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia NCT02567578 · started 2015 · scored riskier than 11% of active trials terminated
- Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia NCT03024086 · started 2016 · scored riskier than 6% 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.