Phase 2Completed
Phase 2B Study Assessing Pain Relief After Replacement of the Knee (SPARK2)
A Phase 2B, Randomized, Double Blind, Placebo and Active Comparator Controlled, Multicenter, Safety, and Efficacy Trial of ATX101 in Adults Undergoing Total Knee Arthroplasty
- Sponsor
- Allay Therapeutics, Inc. (Industry)
- Enrollment
- 226 enrolled
- Conditions
- Total Knee Arthroplasty (Postoperative Pain)
- Interventions
- ATX101; bupivacaine hydrochloride; saline placebo
- Ages
- adults, older adults
- Registry
- NCT06799845
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Area Under the Curve (AUC) for the Numerical Rating Scale at Rest (NRS-R) of Pain Intensity From 30 Minutes Through 168 Hours (Day 8) Compared to Placebo
History
Results first posted
Last registry update
Primary completion
Started
Registered