A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 4% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2015-03-31, after 2013-07-31 start.
Reason given by the sponsor: “other”
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 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: scorepatientdiagnosisacutedisease
Phrases that lowered it: productsinfectedformulationand safetyefficacy and -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 9.4% (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 23.3% (raises risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: double (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 91.6% (raises risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 11446 (lowers risk) · Drug's FDA history
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (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
- 32
- Sponsor's past termination rate
- 9.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 54073 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 11446 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ciprofloxacin, ciprofloxacin dexamethasone, dexamethasone
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 of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes NCT01994642 · started 2013 · scored riskier than 12% of active trials terminated
- FST-201 In The Treatment of Acute Otitis Externa NCT00945802 · started 2009 · scored riskier than 15% of active trials terminated
- Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa NCT02216071 · started 2014 · scored riskier than 11% of active trials completed
- Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa NCT00872209 · started 2009 · scored riskier than 28% of active trials completed
- A Phase III Study of an Otic Formulation in Acute Otitis Externa NCT00750633 · started 2008 · scored riskier than 42% 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.