Efficacy and safety of the TRPV1 agonist RTX-GRT7039 in patients with pain associated with knee osteoarthritis: Results from a phase 3, randomised, placebo-controlled trial
Primary result · Change in WOMAC pain subscale score (0-10) from baselineResult — go to the resultTreatment effect (RTX-GRT7039 minus placebo) −0.11 95% CI −0.50-0.27Authors' conclusion
IA RTX-GRT7039 did not demonstrate a clinically meaningful or statistically significant benefit over placebo for KOA pain relief. The safety profile of RTX-GRT7039 was consistent with previous studies.
Study context
- Population
- Participants with painful, radiographic knee osteoarthritis (KOA) who continued with standard careRTX-GRT7039 n=234, placebo n=235
- Participants
- 234 vs 235
- Comparison
- Intra-articular (IA) RTX-GRT7039 vs placebo, each after 5 mL ropivacaine 0.5% IA
- RTX-GRT7039n = 234
- PLACEBOn = 235
- Primary endpoint
- Change in WOMAC pain subscale score (0-10) from baseline
- Follow-up
- Week 12
Methodological detailsrandomised 1:1, placebo-controlled, doses repeated in the index knee at week 26
- Randomised 1:1
- Placebo-controlled
- Doses repeated in the index knee at week 26
Primary result
As reported in the abstract
Treatment effect (RTX-GRT7039 minus placebo)
−0.11
95% CI −0.50-0.27
P = 0.569
Change by group
RTX-GRT7039
−2.96
change from baseline
PLACEBO
−2.85
change from baseline
RTX-GRT7039vs PLACEBO
treatment effect (RTX-GRT7039 minus placebo) −0.11 (95% CI −0.50-0.27); P = 0.569
Secondary outcomes
| Outcome | Estimate | |
|---|---|---|
| WOMAC pain subscale score, between-group difference · weeks 26 and 52Between RTX-GRT7039 and PLACEBO · direction not stated | between-group difference, week 26 0.03 (95% CI −0.38-0.44) | |
| WOMAC pain subscale score, between-group difference · weeks 26 and 52Between RTX-GRT7039 and PLACEBO · direction not stated | between-group difference, week 52 0.14 (95% CI −0.35-0.63) | |
| −0.500.51Difference (linear scale) |
WOMAC physical function and stiffness subscale scores
- Similar trends were observed
Safety
Treatment-emergent adverse events (TEAEs)
Transient procedural pain · expected
- Treatment-emergent adverse events (TEAEs) — Overall participants reporting TEAEs
- 259 (55.6%)
Original publication
Efficacy and safety of the TRPV1 agonist RTX-GRT7039 in patients with pain associated with knee osteoarthritis: Results from a phase 3, randomised, placebo-controlled trial. Osteoarthritis Cartilage. Published 22 October 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →