Relative Bioavailability of Dextromethorphan Syrup in Comparison to Dextromethorphan Soft Pastilles in Healthy Male and Female Subjects
Model scores of the 29,894 trials active now.
Model score 3% for any early termination, 0% 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 (4,470 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: inabilitymsintervalqtcqt
Phrases that lowered it: healthysubjectsbioavailabilitymaleadministration -
Design: crossover (lowers risk) · Design
-
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 5% (lowers risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Blinding: none (lowers risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports with a death: 22.7% (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 181 (lowers risk) · Sponsor's track record
-
Maximum age: 55 (lowers risk) · Who can join
-
Drug's FAERS reports in the prior 12 months: 4332 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 80 (typical: 32)
- Sponsor's past termination rate
- 5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 181 (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
- 16402 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4332 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- dextromethorphan
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
- Study to Investigate Safety With Special Emphasis on ECG Effects and Tolerability After Oral Doses of Dextromethorphan Hydrobromide Monohydrate in Healthy Male and Female Subjects NCT02191176 · started 2009 · scored riskier than 5% of active trials completed
- A Pharmacokinetic (PK) Study Of PF-00299804 And Dextromethorphan In Healthy Volunteers NCT00999817 · started 2009 · scored riskier than 4% of active trials completed
- Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Dextromethorphan in Healthy Adult Subjects NCT01651325 · started 2012 · scored riskier than 2% of active trials completed
- A PHASE 1, OPEN-LABEL, CROSS-OVER, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF MULTIPLE DOSES OF DS-1971A ON THE SINGLE DOSE PHARMACOKINETICS OF PROBE SUBSTRATES FOR CYP2B6, CYP2C8, CYP2C9, CYP2C19 AND CYP3A4 ENZYMES IN HEALTHY MALE AND FEMALE SUBJECTS NCT02473627 · started 2015 · scored riskier than 1% of active trials completed
- This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples NCT01957189 · started 2013 · scored riskier than 2% 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.