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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    345
  • sponsor
    Allay Therapeutics, Inc.
Updated on 30 June 2022

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.

Details
Condition Acute Postoperative Pain
Treatment Placebo, ATX-101, bupivacaine hydrochloride without epinephrine
Clinical Study IdentifierNCT05260008
SponsorAllay Therapeutics, Inc.
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

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 the study knee or previous arthroplasty, unicompartmental knee arthroplasty, or total knee arthroplasty in the contralateral knee within 6 months prior to screening
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
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