Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (1,463 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-06-15, after 2016-03-07 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 2017-06-15. 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: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Sponsor's past termination rate: 6.2% (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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: applypaincancerdetermined byas determined
Phrases that lowered it: moderate toto severedays beforetabletmg -
Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 77.8% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 22.1% (raises risk) · Drug's FDA history
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Maximum age: 75 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor's past trials: 16 (lowers risk) · Sponsor's track record
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Number of arms: 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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (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
- 16 (typical: 32)
- Sponsor's past termination rate
- 6.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 94534 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 16979 (typical: 412.5)
- Drug's FAERS reports marked serious
- 77.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- oxycodone
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
- Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain NCT02716857 · started 2016 · scored riskier than 23% of active trials completed
- Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain NCT01428583 · started 2010 · scored riskier than 39% of active trials completed
- Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain NCT01167699 · started 2009 · scored riskier than 34% of active trials completed
- Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain NCT01167127 · started 2009 · scored riskier than 33% of active trials completed
- Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients NCT01014559 · started 2010 · scored riskier than 26% of active trials terminated
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.