Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

Model scores of the 29,894 trials active now.

Model score 13% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (1,463 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 2011-10-31. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: controlledsubjects mustto severemoderate toplacebo
  Phrases that lowered it: osteoarthritisevaluateand safetyindexscreening
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Blinding: triple (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 25.8% (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 77.7% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
• Maximum age: 75 (raises risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Responsible party: sponsor (lowers risk) · Design
• Sponsor's past trials: 6 (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.

• Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain NCT01789970 · started 2013 · scored riskier than 27% of active trials completed
• Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain NCT01115569 · started 2010 · scored riskier than 16% of active trials completed
• Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time NCT01240863 · started 2010 · scored riskier than 62% of active trials completed
• Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) NCT00763321 · started 2008 · scored riskier than 7% of active trials completed
• Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) NCT00761150 · started 2008 · scored riskier than 7% 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.