Prilosec Bioequivalence Study in Healthy Volunteers
Model scores of the 29,894 trials active now.
Model score 2% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 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 2013-11-30, after 2013-08-31 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 2013-11-30. 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: surgicalimportantprocedurediseaserandomized
Phrases that lowered it: bioequivalencehealthycrossover20single dose -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 141 (lowers risk) · Sponsor's track record
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Primary purpose: basic science (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 1194 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 10.2% (lowers risk) · Drug's FDA history
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Maximum age: 50 (lowers risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 4 (lowers risk) · Design
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Sponsor's past termination rate: 8.0% (raises risk) · Sponsor's track record
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Blinding: none (lowers risk) · Design
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Drug's FAERS reports before start: 89143 (lowers risk) · Drug's FDA history
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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: 16925 (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
- 1 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- 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
- 50 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1194 (typical: 32)
- Sponsor's past termination rate
- 8.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 141 (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
- 89143 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 16925 (typical: 412.5)
- Drug's FAERS reports marked serious
- 74.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- omeprazole
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 Phase 1 Study to Examine the Pharmacodynamics of Different AZD1722 Formulations NCT02249936 · started 2013 · scored riskier than 1% of active trials completed
- Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France) NCT05038969 · started 2021 · scored riskier than 0% of active trials completed
- Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects NCT04108676 · started 2019 · scored riskier than 1% of active trials completed
- Esomeprazole Bioavailability Study With 40 mg Oral Single Dose Fasted and Fed Administration NCT00889850 · started 2009 · scored riskier than 0% of active trials completed
- A Study to Evaluate the Bioequivalence of Single Oral Dose of Esomeprazole Capsule and Tablet Formulation in Healthy Participants NCT03083639 · started 2017 · scored riskier than 1% 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.