A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.
Model scores of the 29,894 trials active now.
Model score 6% 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 7% of the time (289 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-05-25, after 2022-08-31 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 2023-05-25. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: multipleplacebomsdosesdouble blind
Phrases that lowered it: healthyparticipantsscreeningthe effectadministration -
Disease area, psychiatry: Yes (raises risk) · Disease area
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past trials: 1740 (raises risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 28.9% (raises risk) · Drug's FDA history
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Sponsor's past termination rate: 8.2% (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 207 (lowers risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 184214 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 85.8% (lowers risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (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
- 1740 (typical: 32)
- Sponsor's past termination rate
- 8.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 207 (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
- 184214 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 25613 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 28.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- morphine
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 Safety Study of AZD4041 in Healthy Participants NCT05233085 · started 2021 · scored riskier than 12% of active trials completed
- Study for Naltrexone on the Abuse Potential of Methylphenidate NCT03769064 · started 2018 · scored riskier than 5% of active trials completed
- A SAD, MAD and Food Effect Study to Evaluate the Safety, Tolerability, PK, and PD of AJA001 in Healthy Subjects NCT06019065 · started 2023 · scored riskier than 5% of active trials completed
- A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4041 in Healthy Volunteers NCT04076540 · started 2019 · scored riskier than 10% of active trials completed
- A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants NCT04448561 · started 2020 · scored riskier than 13% 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.