Assessment of the Analgesic Effects of PF-05089771 and Pregabalin in Healthy Volunteers Using Evoked Pain Endpoints
Model scores of the 29,894 trials active now.
Model score 4% 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 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2015-03-31, after 2015-01-31 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 2015-03-31. 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: subject hasplacebo controlleddoublethe subjectsubjects
Phrases that lowered it: healthyblood pressurevolunteersmaledrug -
Sponsor's past termination rate: 15.9% (raises risk) · Sponsor's track record
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Design: crossover (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor's past trials: 1455 (raises risk) · Sponsor's track record
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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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Blinding: double (raises risk) · Design
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Drug's FAERS reports with a death: 10.7% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 190476 (lowers risk) · Drug's FDA history
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Number of arms: 5 (lowers risk) · Design
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Drug's FAERS reports marked serious: 71.3% (lowers risk) · Drug's FDA history
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Maximum age: 55 (lowers risk) · Who can join
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Trials the sponsor started in the prior 2 years: 229 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Disease area, psychiatry: No (lowers risk) · Disease area
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Disease area, neurology: No (lowers risk) · Disease area
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
- 5 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (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
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1455 (typical: 32)
- Sponsor's past termination rate
- 15.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 229 (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
- 190476 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 31555 (typical: 412.5)
- Drug's FAERS reports marked serious
- 71.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ibuprofen, pregabalin
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
- Assessment of the Analgesic Effects of PF-06372865 in Healthy Volunteers Using Evoked Pain Endpoints NCT02238717 · started 2014 · scored riskier than 6% of active trials completed
- Assessment of the Analgesic Effects of PF-06273340 in Healthy Volunteers Using Evoked Pain Endpoints NCT02260947 · started 2014 · scored riskier than 6% of active trials completed
- Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers NCT02725112 · started 2016 · scored riskier than 2% of active trials completed
- The Safety and Tolerability of PF-05089771 Will be Investigated in Healthy Subjects Over a 14 Day Dosing Period. NCT01365637 · started 2011 · scored riskier than 7% of active trials completed
- Cold Pressor Test is Used in This Study to Assess the Effect of PF-06305591 on Pain Intensity Evoked by Cold in Healthy Male Subjects NCT01812265 · started 2013 · scored riskier than 6% 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.