Study Assessing Pain Relief After Replacement of the Knee
Completed · Phase 2 · Has a placebo group
Conditions studied: Total Knee Arthroplasty (Postoperative Pain)
In brief
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.
Key facts
- Study ID
- NCT06799845
- Run by
- Allay Therapeutics, Inc.
- People needed
- 226
- Starts
- 2025-02-03
- Expected to finish
- 2025-10-03
- Last updated by the study team
- 2025-11-04
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Woodland International Research Group, LLC — Little Rock, Arkansas, United States
- Phoenix Clinical Research — Tamarac, Florida, United States
- Atlanta Centre for Medical Research — Atlanta, Georgia, United States
- NextStage Clinical Research — Wichita, Kansas, United States
- Chesapeake Research Group, LLC — Pasadena, Maryland, United States
- First Surgical Hospital — Bellaire, Texas, United States
- Legent Orthopedic Hospital — Carrollton, Texas, United States
- Memorial Hermann Village — Houston, Texas, United States
- Endeavor Clinical Trials, LLC — San Antonio, Texas, United States
- NextStage Clinical Research — San Antonio, Texas, United States
- JBR Clinical Research, LLC — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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