A Phase 3 Study to Evaluate the Efficacy and Safety of Triple Therapy With CJ-12420 in H. Pylori Positive Patients
Model scores of the 29,894 trials active now.
Model score 5% 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 2019-01-24, after 2017-10-17 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 2019-01-24. 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: therapytriplestudy isreceptorthe safety
Phrases that lowered it: safety ofefficacy andand safetyevaluate theto evaluate -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Minimum age: 20 (lowers risk) · Who can join
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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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Drug's FAERS reports with a death: 9.8% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Design: parallel (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 7 (raises risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 80.5% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 37 (lowers risk) · Sponsor's track record
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
- 0 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 75 (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
- 37 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 129464 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17736 (typical: 412.5)
- Drug's FAERS reports marked serious
- 80.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- amoxicillin, clarithromycin, lansoprazole
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
- Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT NCT04128917 · started 2020 · scored riskier than 7% of active trials completed
- Triple Therapy With Tegoprazan in H. Pylori Positive Patients NCT03498456 · started 2018 · scored riskier than 5% of active trials completed
- Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer NCT02761512 · started 2016 · scored riskier than 4% of active trials completed
- Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy NCT00669955 · started 2008 · scored riskier than 26% of active trials completed
- Efficacy of Vonoprazan in Eradication of Resistant Strain of Helicobacter Pylori NCT06414707 · started 2023 · scored riskier than 10% 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.