Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 4% 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 (422 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 2014-04-30, 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 2014-04-30. 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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Sponsor's past termination rate: 100% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: opioidiv trpaindsm ivsymptoms
Phrases that lowered it: subjectmildstudysubjectsdrug -
Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Phase: 3 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Blinding: quadruple (lowers risk) · Design
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Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (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, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 92.6% (raises risk) · Drug's FDA history
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Drug's FAERS reports before start: 7357 (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: 13.4% (lowers risk) · Drug's FDA history
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Maximum age: 65 (raises risk) · Who can join
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Collaborators: 1 (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 6 (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
- industry (typical: academic or other)
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 100% (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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 7357 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1485 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- buprenorphine, buprenorphine naloxone
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
- Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence NCT01848054 · started 2013 · scored riskier than 17% of active trials completed
- An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects NCT01666119 · started 2012 · scored riskier than 21% of active trials completed
- Virginia Opioid Overdose Treatment InitiatVE NCT03818399 · started 2019 · scored riskier than 46% of active trials terminated
- Extended-release Pharmacotherapy for Opioid Use Disorder NCT05164549 · started 2019 · scored riskier than 17% of active trials completed
- Buprenorphine-Fentanyl Interaction Study NCT03747341 · started 2018 · scored riskier than 2% 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.