Study of the Efficacy and Safety of Quiklean® and Klean-Prep With Dulcolax® for the Bowel Preparation Prior to Colonoscopy
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 3% 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
Completed on 2020-01-15, after 2019-06-10 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 2020-01-15. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjects withsubject hasqtcoronarybowel
Phrases that lowered it: and safetysafety ofefficacy andwith historyalcohol -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Minimum age: 20 (lowers risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 9.8% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: single (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports before start: 295390 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 69.6% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 74 (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
- 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
- 7 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 295390 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 47740 (typical: 412.5)
- Drug's FAERS reports marked serious
- 69.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- aspartame, bicarbonate, bisacodyl, dibasic, monobasic, polyethylene glycol, polyethylene glycol bicarbonate
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
- A Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy NCT01984008 · started 2013 · scored riskier than 9% of active trials completed
- Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults. NCT02273167 · started 2014 · scored riskier than 11% of active trials completed
- Efficacy and Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy; NCT06062030 · started 2024 · scored riskier than 6% of active trials completed
- A Safety and Efficacy Study of DCL-101 Compared to GoLYTELY NCT02910440 · started 2017 · scored riskier than 45% of active trials completed
- A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial NCT05670470 · started 2022 · scored riskier than 7% 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.