Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)

Model scores of the 29,894 trials active now.

Model score 16% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (1,304 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-11-25. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: painpatientbowelscalestable
  Phrases that lowered it: and safetychildrenparticipantsefficacy andvisit
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 9.5% (raises risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Blinding: quadruple (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Number of arms: 7 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports with a death: 0.8% (lowers risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 11.4% (lowers risk) · Drug's FDA history
• Maximum age: 18 (raises risk) · Who can join
• Sponsor's past trials: 158 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 9 (lowers risk) · Sponsor's track record
• Responsible party: sponsor (lowers 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.

• Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC) NCT04026113 · started 2019 · scored riskier than 57% of active trials completed
• An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation NCT03120520 · started 2017 · scored riskier than 40% of active trials completed
• Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation NCT05151328 · started 2022 · scored riskier than 10% of active trials completed
• Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years NCT05643534 · started 2022 · scored riskier than 36% of active trials completed
• Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation NCT04110145 · started 2019 · scored riskier than 72% 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.