NCT05260008

Study Assessing Pain Relief After Replacement of the Knee

A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Allay Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2B randomized, double blind, active controlled, multi-center clinical trial to evaluate the safety and efficacy of ATX-101 in participants following total knee arthroplasty. The following is short title and acronym for the study: Study Assessing Pain Relief after Replacement of the Knee (SPARK)

Conditions

• Acute Postoperative Pain

Interventions

Type	Name	Description
DRUG	ATX-101	ATX-101 (bupivacaine) implant, one-time administration into the surgical site
DRUG	ATX-101	ATX-101 (bupivacaine) implant, one-time administration into the surgical site
DRUG	bupivacaine hydrochloride without epinephrine	bupivacaine hydrochloride (125 mg) without epinephrine via local infiltration and/or nerve block

Timeline

• Start date: 2022-06-07
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2022-03-02
• Last updated: 2025-08-14
• Results posted: 2025-08-14

Locations

13 sites across 3 countries: Australia, Canada, United Kingdom

Regulatory

• FDA-regulated drug study