Evaluation of Co-Administration of Betahistine as Adjunctive to Olanzapine in Healthy Subjects
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 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 2010-12-31, after 2010-07-31 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 2010-12-31. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: diabetesmg dldiseasetreatedmellitus
Phrases that lowered it: healthysubjectsbody18 topharmacokinetics -
Sponsor's past termination rate: 40% (raises risk) · Sponsor's track record
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Primary purpose: not given (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Blinding: triple (raises risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 7.9% (lowers risk) · Drug's FDA history
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Responsible party: not given (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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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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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 98.8% (raises risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor's past trials: 5 (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 2 (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
- 1 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- not given (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (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
- 5 (typical: 32)
- Sponsor's past termination rate
- 40% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 342 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 97 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- betahistine
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
- Evaluation of Safety, Drug-Drug Interactions and Pharmacokinetic Profiles of Co-Administration of Betahistine With Olanzapine in Healthy Female Subjects NCT00852956 · started 2009 · scored riskier than 3% of active trials completed
- A Study of Olanzapine After Intranasal and Intramuscular Administration NCT06600477 · started 2023 · scored riskier than 2% of active trials completed
- Fasted Bioequivalence Study of 2 Olanzapine Film-coated Tablets, 5 mg, in Healthy, Adult Male and Female Subjects. NCT05123976 · started 2020 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Olanzapine Tablets, 5 mg Under Fed Study NCT01503424 · started 2011 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Olanzapine Tablets, 5 mg of Dr. Reddy's Under Fasting Conditions NCT01503398 · started 2011 · scored riskier than 0% 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.