Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (213 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 on 2011-09-30, after 2009-12-31 start.
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; it actually ended on 2011-09-30. 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: greater thancardiacgradesyndromethe past
Phrases that lowered it: agedweeks beforeefficacy andand safetyclinical -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 12.5% (lowers risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Number of arms: 1 (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Maximum age: 75 (lowers risk) · Who can join
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
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (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
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 17425 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3558 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- pantoprazole
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
- Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI NCT01005251 · started 2009 · scored riskier than 42% of active trials completed
- Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease NCT01474369 · started 2011 · scored riskier than 12% of active trials completed
- A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients NCT02135107 · started 2013 · scored riskier than 4% of active trials completed
- Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis NCT00770913 · started 2008 · scored riskier than 10% of active trials completed
- An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients NCT01370863 · started 2010 · scored riskier than 38% of active trials terminated
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.