Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers
Model scores of the 29,894 trials active now.
Model score 7% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (112 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2024-06-15, after 2021-01-21 start.
Reason given by the sponsor: “business”
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 2024-06-15. 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: painopioidacute18 yearsanalgesia
Phrases that lowered it: healthyvolunteersnicotineprescribeddisorder -
Sponsor's past termination rate: 12.0% (raises risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 67.6% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 7.5% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 133 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 3 (lowers risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Phase: 2/3 (raises 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
- 2/3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 424 (typical: 32)
- Sponsor's past termination rate
- 12.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 133 (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
- 68407 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6660 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- baclofen
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
- Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain NCT01298765 · started 2011 · scored riskier than 15% of active trials completed
- Oral Buprenorphine as a Novel Low-dose Induction Strategy for Opioid Use Disorder NCT06086275 · started 2024 · scored riskier than 3% of active trials completed
- Acute Pain Management in Patients on Opioid Replacement Therapy NCT03933865 · started 2018 · scored riskier than 30% of active trials terminated
- Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals NCT01262092 · started 2010 · scored riskier than 49% of active trials completed
- Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone NCT01760473 · started 2009 · scored riskier than 5% 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.