A 5-treatment, Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release (CR) Pregabalin Tablet Formulations and the Immediate Release (IR) Formulation Administered Fasted

NCT01443169 on ClinicalTrials.gov Phase 1 Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (industry) Started 2012-03-31 Completed

Riskier than 1% of active trials

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 on 2012-04-30, after 2012-03-31 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 2012-04-30. 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: Yes (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: qtcmsecbowelsafety tolerabilityto determine
Phrases that lowered it: tablethealthysingle doseopen labelmg
Design: crossover (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Sponsor's past termination rate: 9.3% (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 5.6% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 52 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past trials: 289 (lowers risk) · Sponsor's track record
Primary purpose: basic science (lowers risk) · Design
Drug's FAERS reports marked serious: 71.0% (lowers risk) · Drug's FDA history
Number of arms: 4 (lowers risk) · Design
Disease area, psychiatry: No (lowers risk) · Disease area
Blinding: none (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports before start: 37509 (lowers risk) · Drug's FDA history

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: 4 (typical: 2)
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: basic science (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (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: 289 (typical: 32)
Sponsor's past termination rate: 9.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 52 (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: 37509 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 7968 (typical: 412.5)
Drug's FAERS reports marked serious: 71.0% (typical: 85.6%)
Drug's FAERS reports with a death: 5.6% (typical: 15.9%)

Disease area and drugs

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

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

Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers NCT02725112 · started 2016 · scored riskier than 2% of active trials completed
Bioequivalence Study of Two Formulations of Pregabalin CR(Controlled-release) Table 300 mg NCT02952937 · started 2016 · scored riskier than 1% of active trials completed
Bioequivalence Study of Two Formulations of Pregabalin CR (Controlled-release) Table 150 mg NCT02955472 · started 2016 · scored riskier than 1% of active trials completed
Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation NCT02103647 · started 2013 · scored riskier than 0% of active trials completed
Study for Comparing The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects NCT02103686 · started 2012 · 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.