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Completed Phase 2 Interventional

Study Assessing Pain Relief After Replacement of the Knee

ClinicalTrials.gov ID: NCT06799845

Public ClinicalTrials.gov record NCT06799845. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 9:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06799845
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Allay Therapeutics, Inc.
Industry
Enrollment
226 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 3, 2025 (Actual)
Primary completion
Oct 3, 2025 (Actual)
Completion
Oct 3, 2025 (Actual)
Last update posted
Nov 4, 2025

2025

United States locations

U.S. sites
11
U.S. states
7
U.S. cities
10
Facility City State ZIP Site status
Woodland International Research Group, LLC Little Rock Arkansas 72211 —
Phoenix Clinical Research Tamarac Florida 33321 —
Atlanta Centre for Medical Research Atlanta Georgia 30331 —
NextStage Clinical Research Wichita Kansas 67214 —
Chesapeake Research Group, LLC Pasadena Maryland 21122 —
First Surgical Hospital Bellaire Texas 77401 —
Legent Orthopedic Hospital Carrollton Texas 75006 —
Memorial Hermann Village Houston Texas 77043 —
Endeavor Clinical Trials, LLC San Antonio Texas 78240 —
NextStage Clinical Research San Antonio Texas 78258 —
JBR Clinical Research, LLC Salt Lake City Utah 84107 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06799845, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 4, 2025 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06799845 live on ClinicalTrials.gov.

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