A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain

Summary

This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the analgesic efficacy and safety of a single intra-articular (IA) CNTX-4975-05 (capsaicin), compared to IA placebo, in subjects with chronic, moderate-to-severe osteoarthritis (OA) knee pain.

Timeline

Start

2018-01-24

Primary completion

2019-11-22

Completion

2019-11-22

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs CNTX-4975-05; p = 0.1904; Least Squares Mean Difference -0.33 (95% CI -0.84 to 0.17); Mixed Models Analysis NCT03429049 ↗

Drugs

Indications