A Bioequivalence Study of 2 Formulations of Rabeprazole Sodium and Evaluation of the Effect of Food on Rabeprazole Sodium in Healthy Adult Volunteers

NCT01241409 on ClinicalTrials.gov Phase 1 Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (industry) Started 2010-10-31 Completed

Among the lowest-risk 1% of active trials

Model scores of the 29,894 trials active now.

Model score 2% 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 on 2010-12-31, after 2010-10-31 start.

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; it actually ended on 2010-12-31. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: surgerytraumaticusetherapyheparin
Phrases that lowered it: healthyformulationvolunteersbioequivalencethe pharmacokinetics
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Primary purpose: not given (lowers risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Drug's FAERS reports with a death: 9.1% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: none (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 68 (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 9.0% (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Maximum age: 55 (lowers risk) · Who can join
Drug's FAERS reports marked serious: 70.4% (lowers risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Sponsor's past trials: 378 (lowers risk) · Sponsor's track record

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: 6 (typical: 2)
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: not given (typical: treatment)
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 6 (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: 378 (typical: 32)
Sponsor's past termination rate: 9.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 68 (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: 7109 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1203 (typical: 412.5)
Drug's FAERS reports marked serious: 70.4% (typical: 85.6%)
Drug's FAERS reports with a death: 9.1% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: rabeprazole

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 Relative Bioavailability Study of Rabeprazole Sodium Administered With Different Dosing Vehicles in Healthy Adult Volunteers NCT01186497 · started 2010 · scored riskier than 0% of active trials completed
A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers NCT01101646 · started 2008 · scored riskier than 0% of active trials completed
A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810) NCT01202071 · started 2010 · scored riskier than 1% of active trials completed
A Bioequivalence Study of Rabeprazole From Idiazole 20mg DR Tabs (GSK, Egypt) and PARIET 20 mg DR Tabs (JANSSEN, EGYPT) NCT02477306 · started 2014 · scored riskier than 0% of active trials completed
Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France) NCT05038969 · started 2021 · scored riskier than 0% 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.