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Study Assessing Pain Relief After Replacement of the Knee

NCT06799845 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2025-11-04

No results posted yet for this study

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.

Conditions

  • Total Knee Arthroplasty (Postoperative Pain)

Interventions

DRUG

ATX101

ATX101 bupivacaine implants, total of 1,500 mg into the surgical site

DRUG

bupivacaine hydrochloride

bupivacaine hydrochloride 0.25% without epinephrine/adrenaline, total 125 mg in 50 mL via local periarticular infiltration

DRUG

saline placebo

normal saline (0.9%) sodium chloride, total volume of up to 17 mL via local periarticular infiltration

Sponsors & Collaborators

  • Allay Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Hewitt, MD · Allay Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2025-10-03
Completion
2025-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06799845 on ClinicalTrials.gov