Ibuprofen Bioavailability Trial With Oral Single Dose Administration.
Model scores of the 29,894 trials active now.
Model score 2% 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 11% of the time (918 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-10-31, after 2016-09-30 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 2016-10-31. 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: cnsulnactivehearttherapy
Phrases that lowered it: the pharmacokineticspharmacokinetics ofbioequivalencehealthysingle dose -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Primary purpose: not given (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports in the prior 12 months: 28812 (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: 12.8% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Blinding: none (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 70.4% (lowers risk) · Drug's FDA history
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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
- 3 (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
- 1 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (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
- 154998 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 28812 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ibuprofen
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
- Bioequivalence Study of Ibuprofen 200 mg/5 mL Oral Suspension vs. MOMENT 200 mg Coated Tablet NCT02902289 · started 2016 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Test and Reference 400 mg Ibuprofen Coated Tablets in Healthy Volunteers NCT05663398 · started 2022 · scored riskier than 0% of active trials completed
- A Study Comparing Three Formulations of Ibuprofen in Healthy Subjects NCT02256423 · started 2014 · scored riskier than 1% of active trials completed
- To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Modified-Release Tablets 800 mg NCT05329454 · started 2020 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Ibuprofen 400 mg/10 mL Oral Suspension vs. MOMENTACT 400 mg Film-coated Tablet NCT02902302 · started 2016 · scored riskier than 0% 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.