Study Investigating STA363 Compared to Placebo in Patients With Chronic Discogenic Low Back Pain
Model scores of the 29,894 trials active now.
Model score 9% 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 13% of the time (1,304 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-10-31, after 2020-07-31 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2023-10-31. 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.
What moved the score
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: mrichronicgradeknownspinal
Phrases that lowered it: the efficacythe investigatorand safetyefficacy andpatients -
Phase: 2 (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 23.3% (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: 70 (lowers risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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
- 2
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 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
- 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
- 994 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 158 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- lactic acid
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
- STA363 in the Treatment of Lumbar Disc Herniation NCT06022263 · started 2023 · scored riskier than 16% of active trials completed
- A Single Ascending Dose Study of Safety and Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain NCT03055845 · started 2017 · scored riskier than 13% of active trials completed
- AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain NCT03263611 · started 2018 · scored riskier than 28% of active trials completed
- Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain NCT03952377 · started 2019 · scored riskier than 30% of active trials terminated
- Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain NCT02412735 · started 2015 · scored riskier than 42% 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.