clinical trial · NCT06799845
Study Assessing Pain Relief After Replacement of the Knee
Allay Therapeutics, Inc.·phase2·completed·n = 226
Total Knee Arthroplasty (Postoperative Pain)ATX101bupivacaine hydrochloridesaline placebo
brief summary
The goal of the ATX101-TKA-004 clinical trial aims to evaluate the efficacy and safety of ATX101 1,500 mg in participants undergoing primary unilateral total knee arthroplasty. The study will compare the effectiveness of ATX101 with a saline placebo and bupivacaine, an active comparator. Additionally, it will assess opioid consumption among participants receiving ATX101 versus those given the saline placebo and bupivacaine. The trial will also focus on the safety and tolerability of ATX101 in the participants.
started
Feb 3, 2025
primary completion
Oct 3, 2025
completion
Oct 3, 2025
last updated
Nov 4, 2025
official title
A Phase 2B, Randomized, Double Blind, Placebo and Active Comparator Controlled, Multicenter, Safety, and Efficacy Trial of ATX101 in Adults Undergoing Total Knee Arthroplasty
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol