Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (103 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 2011-02-16, after 2010-08-02 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 2011-02-16. 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
-
Sponsor's past termination rate: 24.3% (raises risk) · Sponsor's track record
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: or equalbreastequal tostablediabetes
Phrases that lowered it: kneetopicalosteoarthritisoagel -
Minimum age: 40 (lowers risk) · Who can join
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Drug's FAERS reports with a death: 12.5% (lowers risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 3 (lowers risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
Sponsor's past trials: 37 (lowers risk) · Sponsor's track record
-
Disease area, neurology: No (lowers risk) · Disease area
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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 40 (typical: 18)
- Maximum age
- 85 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 37 (typical: 32)
- Sponsor's past termination rate
- 24.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 13338 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2778 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- musculoskeletal
- 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
- 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
- Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee NCT05007808 · started 2021 · scored riskier than 10% 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
- Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1% NCT02913521 · started 2015 · scored riskier than 8% of active trials completed
- AMZ001 for the Treatment of Knee Osteoarthritis Symptoms NCT03691844 · started 2018 · scored riskier than 8% 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.