Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
Model scores of the 29,894 trials active now.
Model score 16% 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 in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-09-15, after 2016-04-30 start.
Reason given by the sponsor: “other”
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 2020-09-15. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 13.6% (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 39.5% (raises risk) · Drug's FDA history
-
Phase: 3 (lowers risk) · Design
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectacuteconditionnervoussurgery
Phrases that lowered it: evaluate theto evaluatethe efficacypharmacokineticshealthy -
Disease area, cancer: No (lowers risk) · Disease area
-
Number of arms: 3 (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 70.0% (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, neurology: No (lowers risk) · Disease area
-
Responsible party: sponsor (lowers risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Drug's FAERS reports before start: 1892 (raises risk) · Drug's FDA history
-
Minimum age: 0 (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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 0 (typical: 18)
- Maximum age
- 2 (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
- 59 (typical: 32)
- Sponsor's past termination rate
- 13.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 1892 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 657 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 39.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- oxymorphone
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
- Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects NCT01210352 · started 2010 · scored riskier than 42% of active trials completed
- Study of Oral Morphine Sulfate Administration in Pediatric Subjects NCT03429400 · started 2018 · scored riskier than 36% of active trials completed
- Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects. NCT00801398 · started 2009 · scored riskier than 14% of active trials completed
- Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients NCT02321319 · started 2017 · scored riskier than 18% of active trials terminated
- Pharmacokinetics and Safety of ORF Tablets in Pediatric Patients NCT01160614 · started 2010 · scored riskier than 26% 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.