Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (145 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-05-25, after 2016-10-24 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 2018-05-25. 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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Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports with a death: 52.5% (raises risk) · Drug's FDA history
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Phase: 1 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: to determineplacebo controlledintravenousblind placebosafe
Phrases that lowered it: safety ofdrugacidthe studymoderate -
Sponsor's past termination rate: 5% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 96.1% (raises risk) · Drug's FDA history
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Collaborators: 2 (lowers risk) · Design
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Sponsor's past trials: 60 (lowers 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 before start: 7160 (raises risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 14 (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
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 60 (typical: 32)
- Sponsor's past termination rate
- 5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 14 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 7160 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 710 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 52.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- clavulanic acid, cocaine
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
- Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid NCT04411914 · started 2020 · scored riskier than 20% of active trials completed
- Open Label Pharmaco- Magnetic Resonance Spectrography (MRS) Study of Clavulanic Acid NCT03986762 · started 2019 · scored riskier than 30% of active trials completed
- Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD) NCT03242928 · started 2017 · scored riskier than 35% of active trials completed
- Behavioral and Physiological Effects of Cocaine in Cocaine-dependent Participants Treated With Levodopa in Combination With Carbidopa and Entacapone (LCE) NCT01437293 · started 2010 · scored riskier than 27% of active trials completed
- Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin NCT02393599 · started 2015 · scored riskier than 8% 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.