Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants

NCT01511939 on ClinicalTrials.gov Phase 3 Nathan Wei, MD, FACP, FACR: (academic or other) Started 2012-02-29 Completed

Riskier than 25% of active trials

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (381 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 2013-05-31, after 2012-02-29 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 2013-05-31. 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) (raises risk) · Wording Phrases that raised it: subjectssubjectscreeningmalesingle
Phrases that lowered it: kneecellulncarcinomacount
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 55 (lowers risk) · Who can join
Responsible party: sponsor investigator (raises risk) · Design
Design: single group (raises risk) · Design
Drug's FAERS reports with a death: 12.0% (lowers risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Disease area, cardiovascular: Yes (raises risk) · Disease area
Phase: 3 (lowers risk) · Design
Primary purpose: supportive care (lowers risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Number of arms: 3 (lowers risk) · Design
Collaborators: 2 (lowers risk) · Design
Drug's FAERS reports marked serious: 88.9% (raises risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Maximum age: not given (raises risk) · Who can join

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: 3 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: supportive care (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor investigator (typical: sponsor)
Collaborators: 2 (typical: 0)
Keywords listed: 8 (typical: 1)

Who can join

Minimum age: 55 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 0 (typical: 32)
Sponsor's past termination rate: no earlier finished trials (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 1 (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: 18635 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3601 (typical: 412.5)
Drug's FAERS reports marked serious: 88.9% (typical: 85.6%)
Drug's FAERS reports with a death: 12.0% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular, musculoskeletal, hematology
Drugs matched to FDA substances: diclofenac

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

Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1% NCT02913521 · started 2015 · scored riskier than 8% of active trials completed
Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis NCT01119898 · started 2010 · scored riskier than 22% of active trials completed
Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel NCT01202799 · started 2010 · scored riskier than 1% of active trials completed
Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1% NCT01456611 · started 2011 · scored riskier than 7% of active trials completed
A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms NCT06693648 · started 2025 · scored riskier than 5% 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.