ATX-101 for Post-surgical Pain Following Total Knee Arthroplasty

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2B randomized, double blind, placebo and active controlled, multi-center clinical trial to evaluate the safety and efficacy of ATX-101 in participants following total knee arthroplasty.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allay Therapeutics, Inc.
• Treatments: Bupivacaine; Epinephrine

Criteria

Inclusion Criteria:

• Primary indication of total knee arthroplasty is knee pain due to osteoarthritis or post-traumatic arthritis.

• Scheduled to undergo primary unilateral total knee arthroplasty with a cemented prosthesis, without use of a surgical drain, and under bupivacaine spinal anesthesia (dextrose is permitted).

• American Society of Anesthesiology (ASA) Physical Classification System of class 1, 2 or 3.

Exclusion Criteria:

• Has a planned concurrent surgical procedure.

• Has had any previous arthroplasty, unicompartmental knee arthroplasty or total knee arthroplasty in either knee.

• Has been administered any type of intra-articular injection within 3 months of surgery in the trial knee.

• Immunocompromised or has a known history of Hepatitis B, human immunodeficiency virus (HIV), or Hepatitis C.

• Routinely take opioid analgesics and are expected to require opioid analgesics in the postsurgical period that is not strictly related to the trial.

• Unable to abstain from opioid use for knee pain within 14 days of surgery.

• Has been administered systemic steroids within 14 days prior to surgery.

• Has been administered any local anesthetic within 5 days prior to the scheduled surgery.

• Screening electrocardiogram (ECG) with significant abnormalities associated with significant heart disease.

• Has a contraindication or a known suspected history of allergy, hypersensitivity or idiosyncratic reaction to trial medications.

• Has uncontrolled depression, anxiety, psychiatric, or neurological disorder that might interfere with trial study assessments.

• Has a medical condition or receiving medication such that, in the opinion of the investigator, participating in the trial would pose a health risk to the subject or might interfere with the study outcome.

• Has a known or suspected history of drug or alcohol abuse. A subject with a history of alcohol use disorder that has ≥10 years sobriety will be permitted.

• Has received/used an investigational drug, product, or device for a clinical trial within 30 days of screening. COVID-19 vaccines are permitted if the subject is not in a clinical trial for the vaccine.

• Has a Body Mass Index (BMI) ≥40 kg/m2.