Lansoprazole in Preterm Infants With Reflux
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (136 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 2013-06-30, after 2013-01-31 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 2013-06-30. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: infantspretermgastrointestinal tractinfantcongenital
Phrases that lowered it: gastrointestinalrefluxefficacyevaluatemedication -
Sponsor's past termination rate: 4.0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Maximum age: 0.33 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 140 (lowers risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports with a death: 11.1% (lowers risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Sponsor's past trials: 151 (lowers risk) · Sponsor's track record
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Minimum age: not given (raises risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports in the prior 12 months: 6163 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 79.4% (lowers risk) · Drug's FDA history
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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 0.33 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 151 (typical: 32)
- Sponsor's past termination rate
- 4.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 140 (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
- 35704 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6163 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- 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
- Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER) NCT01946971 · started 2013 · scored riskier than 10% of active trials completed
- A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD) NCT00855361 · started 2009 · scored riskier than 29% of active trials completed
- Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD) NCT00992589 · started 2009 · scored riskier than 13% of active trials completed
- Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants NCT00744419 · started 2009 · scored riskier than 21% of active trials completed
- Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD) NCT02527798 · started 2015 · scored riskier than 38% 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.