A Randomized, Double-blind, Phase III Trial in Moderate Osteoarthritis Knee Pain Comparing Topical Ketoprofen Gel with Ketoprofen-free Gel
Bibliographic record
Abstract
OBJECTIVE: This randomized, double-blind, phase III study evaluated the efficacy and safety of ketoprofen in an ultradeformable vesicle gel compared with ketoprofen-free gel in osteoarthritis (OA) knee pain. METHODS: Patients with American College of Rheumatology-defined OA of the knee and moderate pain were randomized to receive 100 mg ketoprofen in 4.4 g transfersome gel (IDEA-033) or 4.4 g ketoprofen-free vehicle (TDT 064) topically, twice daily, for 12 weeks. The primary endpoint was mean change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score from baseline to Week 12. RESULTS: Patients (n = 555) were randomized and treated. Mean baseline WOMAC pain scores were 5.2 (SD 1.0) for IDEA-033 and 5.3 (SD 1.0) for TDT 064. Mean change in WOMAC pain scores from baseline to Week 12 was 38.6% for IDEA-033 and 44.6% for TDT 064 (Mann-Whitney estimator 0.4505; p = 0.022). Both groups reported progressive decreases in pain and improvements in function and stiffness. Mean baseline WOMAC function scores decreased from 5.4 to 3.4 with IDEA-033 and 3.1 with TDT 064 at Week 12. The proportion of patients achieving ≥ 50% decrease in WOMAC pain score from baseline at Week 12 was 41.2% (95% CI 0.35-0.47) with IDEA-033 and 50.5% (95% CI 0.45-0.57) with TDT 064. Mild skin and subcutaneous tissue disorders were the most frequently reported treatment-related adverse events (AE). CONCLUSIONS: IDEA-033 was inferior to drug-free gel (TDT 064) in relieving moderate OA knee pain and improving joint function.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".