Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 15% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (159 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 2016-12-31, after 2014-10-07 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 2016-12-31. 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) (raises risk) · Wording
Phrases that raised it: patientsdiseaserecurrentbowelcancers
Phrases that lowered it: dailylong termdayeffectstudy -
Sponsor's past termination rate: 14.9% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 16.7% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 28 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Blinding: none (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports marked serious: 87.4% (lowers risk) · Drug's FDA history
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Keywords listed: 0 (raises risk) · Design
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 47 (typical: 32)
- Sponsor's past termination rate
- 14.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 28 (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
- 12241 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2186 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- loperamide
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
- Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study NCT02266849 · started 2014 · scored riskier than 8% of active trials terminated
- Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study NCT02354768 · started 2015 · scored riskier than 56% of active trials terminated
- Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients (BUTYCLO) NCT04795180 · started 2013 · scored riskier than 35% of active trials completed
- Prucalopride in Postoperative Ileus NCT02947269 · started 2017 · scored riskier than 31% of active trials completed
- Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer NCT01345175 · started 2011 · scored riskier than 30% 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.