A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 3% 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 2018-05-29. 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) (lowers risk) · Wording Phrases that raised it: randomizationpatiententrychildrenbms
  Phrases that lowered it: participantparticipantssafetyefficacyhistory
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 10% (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Phase: 2 (raises risk) · Design
• Design: parallel (raises risk) · Design
• Drug's FAERS reports marked serious: 28.3% (lowers risk) · Drug's FDA history
• Drug's FAERS reports with a death: 1.2% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Blinding: quadruple (lowers risk) · Design
• Number of arms: 5 (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 12 (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Sponsor's past trials: 120 (lowers risk) · Sponsor's track record
• Maximum age: 17 (raises risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Minimum age: 6 (lowers risk) · Who can join
• Collaborators: 1 (raises risk) · Design
• Drug's FAERS reports before start: 3111 (raises 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.

• A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation NCT02559817 · started 2015 · scored riskier than 25% of active trials terminated
• A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide NCT05760313 · started 2023 · scored riskier than 65% of active trials completed
• A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation NCT05652205 · started 2022 · scored riskier than 49% of active trials completed
• Trial of Linaclotide in Patients With Chronic Constipation NCT00730015 · started 2008 · scored riskier than 11% of active trials completed
• Lubiprostone for Functional Constipation in the Under 18 Years Patients NCT05144295 · started 2022 · scored riskier than 12% 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.