CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
Model scores of the 29,894 trials active now.
Model score 16% 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 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
Terminated on 2021-12-13, after 2020-12-18 start.
Reason given by the sponsor: “enrollment”
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 2021-12-13. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Drug's FAERS reports with a death: 34.8% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor's past termination rate: 4.7% (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Blinding: triple (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Minimum age: not given (raises risk) · Who can join
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Maximum age: 0.02 (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: opioidglucosehypoglycemiasyndromeparticipation
Phrases that lowered it: evaluate theto evaluatepharmacokineticsthe efficacyencephalopathy -
Number of arms: 2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 8 (raises risk) · Sponsor's track record
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Sponsor's past trials: 106 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Collaborators: 0 (raises risk) · Design
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 0.02 (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
- 106 (typical: 32)
- Sponsor's past termination rate
- 4.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (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
- 137216 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 18552 (typical: 412.5)
- Drug's FAERS reports marked serious
- 82.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 34.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- morphine
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
- Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome NCT01452789 · started 2011 · scored riskier than 72% of active trials completed
- Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women NCT01965704 · started 2014 · scored riskier than 58% of active trials completed
- Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants NCT01360450 · started 2011 · scored riskier than 66% of active trials terminated
- Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines NCT01671410 · started 2012 · scored riskier than 49% of active trials completed
- First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome NCT01651637 · started 2012 · scored riskier than 13% 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.