A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis

Model scores of the 29,894 trials active now.

Model score 10% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (213 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.

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.

• Primary purpose: not given (lowers risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: randomizationcolitisulcerativediseasescreening
  Phrases that lowered it: mildmoderatesafety ofpatientsdaily
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 7.6% (lowers risk) · Drug's FDA history
• Number of arms: 3 (lowers risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Responsible party: not given (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Blinding: not given (lowers risk) · Design
• Maximum age: not given (raises risk) · Who can join
• Sponsor's past trials: 0 (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.

• Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis. NCT00737789 · started 2008 · scored riskier than 51% of active trials completed
• Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis NCT01059344 · started 2009 · scored riskier than 17% of active trials completed
• (CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis NCT00679380 · started 2008 · scored riskier than 14% of active trials completed
• Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis NCT01149707 · started 2010 · scored riskier than 26% of active trials completed
• A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis NCT01805791 · started 2013 · scored riskier than 68% of active trials terminated

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.