Pharmacokinetics Of Celecoxib Test Formulations
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 5% of the time (4,470 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 2009-08-31, after 2009-07-31 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 2009-08-31. 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: evidencepsychiatricneurologicaldiseasecharacteristics
Phrases that lowered it: bioavailabilityvolunteershealthycrossoverformulations -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Blinding: none (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
-
Number of arms: 4 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 47 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 12.0% (lowers risk) · Drug's FDA history
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Maximum age: 55 (lowers risk) · Who can join
-
Primary purpose: basic science (raises risk) · Design
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Drug's FAERS reports before start: 23806 (raises risk) · Drug's FDA history
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Sponsor's past termination rate: 8.4% (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 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
- 215 (typical: 32)
- Sponsor's past termination rate
- 8.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 47 (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
- 23806 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2247 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- celecoxib
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
- Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib NCT00729495 · started 2008 · scored riskier than 1% of active trials completed
- A Pilot Open-Label Crossover Bioavailability Study of Celecoxib in Healthy Volunteers NCT00813241 · started 2009 · scored riskier than 2% of active trials completed
- Bioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State NCT00861458 · started 2009 · scored riskier than 2% of active trials completed
- A Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy Subjects NCT01289509 · started 2010 · scored riskier than 0% of active trials completed
- A Single-Center, Open-Label, Randomized, 3-Treatment Crossover Bioavailability Study of Single Oral Doses of E5501 Old Tablet Formulation Under Fasted Conditions and a New Tablet Formulation Under Fed and Fasted Conditions in Healthy Subjects NCT01260155 · started 2010 · 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.