Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 6% 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 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 2014-03-31. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Drug's FAERS reports with a death: 38.4% (raises risk) · Drug's FDA history
• Has a data monitoring committee: not given (lowers risk) · Design
• Sponsor's past termination rate: no earlier finished trials (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
• Design: parallel (raises risk) · Design
• Number of arms: 2 (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 0.17 (lowers risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Maximum age: 12 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: 92.4% (raises risk) · Drug's FDA history
• Blinding: double (raises risk) · Design
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: painchronicpatientspriorweeks
  Phrases that lowered it: infectedhealthmedicationclinicalefficacy
• Collaborators: 0 (raises risk) · Design
• 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.

• Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children NCT03116737 · started 2017 · scored riskier than 19% of active trials completed
• Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007) NCT02074007 · started 2013 · scored riskier than 11% of active trials terminated
• Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media NCT02037893 · started 2013 · scored riskier than 20% of active trials completed
• Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media NCT02044341 · started 2013 · scored riskier than 11% of active trials completed
• Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media NCT01588535 · started 2012 · scored riskier than 54% 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.