A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers
Model scores of the 29,894 trials active now.
Model score 1% 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 6% of the time (816 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 2008-08-31, after 2008-05-31 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 2008-08-31. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: receiptmultipleinfluenzaimmediatetherapy
Phrases that lowered it: subjectshealthyvolunteersmalescreening -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Primary purpose: not given (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Keywords listed: 14 (raises risk) · Design
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Drug's FAERS reports with a death: 15.2% (lowers risk) · Drug's FDA history
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Maximum age: 55 (lowers risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 7717 (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 7 (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: none (lowers risk) · Design
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Drug's FAERS reports before start: 34984 (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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
- 7 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 14 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 11 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 34984 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7717 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- acetaminophen, tramadol
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
- Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers NCT00839072 · started 2009 · scored riskier than 0% of active trials completed
- Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin NCT02157649 · started 2014 · scored riskier than 1% of active trials completed
- Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers NCT05014490 · started 2021 · scored riskier than 0% of active trials completed
- Codeine Phosphate/Guaifenesin ER Tablet 30 mg/600 mg Steady State Clinical Study NCT02572375 · started 2014 · scored riskier than 1% of active trials completed
- Clinical Study to Assess the Pharmacokinetics, Safety, and Tolerability of ACT-129968 in Healthy Subjects NCT01877629 · started 2011 · scored riskier than 1% 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.