Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients
Model scores of the 29,894 trials active now.
Model score 31% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 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
Terminated on 2008-09-30, after 2008-07-31 start.
Reason given by the sponsor: “enrollment”
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 2008-09-30. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: painto determinepurposegreaterlikely
Phrases that lowered it: astopen labelefficacypatients whorespiratory -
Sponsor's past termination rate: 30% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 42.7% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Design: single group (raises risk) · Design
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Sponsor's past trials: 10 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports marked serious: 90.3% (raises risk) · Drug's FDA history
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Blinding: none (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 8 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 10 (typical: 32)
- Sponsor's past termination rate
- 30% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (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
- 4375 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1072 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 42.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- methadone
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 the Efficacy and Safety of Two Methadone Titration Methods for the Treatment of Cancer-related Pain With Inadequate Pain Relief or Intolerable Side Effects When Treated With Level 3 Opioids. NCT01793480 · started 2012 · scored riskier than 9% of active trials completed
- Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cancer Pain NCT00930332 · started 2010 · scored riskier than 86% of active trials terminated
- Sublingual Fentanyl for the Management of Breakthrough Pain NCT02514252 · started 2016 · scored riskier than 99% of active trials terminated
- Morphine Versus Methadone As First Line Strong Opioid for Cancer Pain NCT00634010 · started 2008 · scored riskier than 97% of active trials terminated
- Fentanyl Sublingual Spray in Opioid Naive Participants NCT02641340 · started 2016 · 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.