A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation

NCT01080612 on ClinicalTrials.gov Phase 1 Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (industry) Started 2010-04-30 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 2010-06-30, after 2010-04-30 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 2010-06-30. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: controlledpregabalindeterminetolerabilitypotential
Phrases that lowered it: the pharmacokineticshealthysingle doseopen labelpharmacokinetics of
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Primary purpose: other (lowers risk) · Design
Drug's FAERS reports with a death: 6.4% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 51 (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Blinding: none (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Maximum age: 55 (lowers risk) · Who can join
Minimum age: 18 (raises risk) · Who can join
Number of arms: 4 (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Sponsor's past termination rate: 8.5% (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: 4 (typical: 2)
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: other (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: 235 (typical: 32)
Sponsor's past termination rate: 8.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 51 (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: 15481 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2848 (typical: 412.5)
Drug's FAERS reports marked serious: 89.2% (typical: 85.6%)
Drug's FAERS reports with a death: 6.4% (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

An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers NCT01270815 · started 2011 · scored riskier than 0% of active trials completed
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers NCT01291524 · started 2011 · scored riskier than 0% of active trials completed
An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers NCT01257529 · started 2011 · scored riskier than 0% of active trials completed
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule NCT01202435 · started 2010 · scored riskier than 1% of active trials completed
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers NCT01257516 · started 2011 · scored riskier than 1% 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.