Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 13% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (136 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 2009-05-31, after 2009-01-31 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 2009-05-31. 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: boweldiarrheapatientssyndromeibs
Phrases that lowered it: participantsevaluate theagedto evaluatestudy to -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 28.8% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
-
Design: parallel (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Responsible party: not given (raises risk) · Design
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Drug's FAERS reports with a death: 0% (raises risk) · Drug's FDA history
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Sponsor's past termination rate: 7.5% (lowers risk) · Sponsor's track record
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Maximum age: 65 (lowers risk) · Who can join
-
Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 118 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Keywords listed: 6 (lowers risk) · Design
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Sponsor's past trials: 161 (lowers risk) · Sponsor's track record
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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 6 (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
- academic or other
- Sponsor's past trials
- 161 (typical: 32)
- Sponsor's past termination rate
- 7.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 118 (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
- 52 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 36 (typical: 412.5)
- Drug's FAERS reports marked serious
- 28.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive, metabolic
- Drugs matched to FDA substances
- colesevelam
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
- Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption NCT03270085 · started 2017 · scored riskier than 63% of active trials completed
- Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS) NCT01327300 · started 2010 · scored riskier than 42% of active trials completed
- Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome NCT01786109 · started 2009 · scored riskier than 71% of active trials completed
- Cheno Effect on Transit in Health and IBS-C NCT00912301 · started 2009 · scored riskier than 14% of active trials completed
- Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS) NCT01253408 · started 2009 · scored riskier than 73% 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.