A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
Model scores of the 29,894 trials active now.
Model score 4% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (176 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.
How it ended
Completed.
The score above never used this outcome: 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.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start. 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.
What moved the score
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: diseaseacutepatients withstablepain
Phrases that lowered it: to investigateinvestigate thecrossovereffectsubjects -
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Disease area, digestive: Yes (raises risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, neurology: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Maximum age: 70 (lowers risk) · Who can join
-
Has a data monitoring committee: No (lowers risk) · Design
-
Blinding: double (raises risk) · Design
-
Drug's FAERS reports marked serious: no FAERS history (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.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- none matched
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Study to Investigate the Effect of ONO-8539 on Acid-Induced Oesophageal Hypersensitivity in Healthy Volunteers NCT01705275 · started 2013 · scored riskier than 2% of active trials completed
- Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD) NCT01019928 · started 2009 · scored riskier than 10% of active trials completed
- A Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus NCT01818570 · started 2013 · scored riskier than 2% of active trials completed
- Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD) NCT00730665 · started 2008 · scored riskier than 53% of active trials terminated
- Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients NCT01872897 · started 2013 · scored riskier than 14% 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.