COMPLETED

Study Assessing Pain Relief After Replacement of the Knee

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-02-03
Study Completion:2025-10-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06799845

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary indication of TKA is knee pain due to osteoarthritis or post-traumatic arthritis
  2. * Scheduled to undergo primary unilateral TKA with a cemented prosthesis, without use of a surgical drain, and under bupivacaine spinal anesthesia (dextrose is permitted)
  3. * American Society of Anesthesiology (ASA) Physical Classification System of class 1, 2, or 3
  4. * Capable, able, and willing to comply with all trial visits and procedures. Participant must also be able to use trial required e-diary and demonstrate completion compliance during the screening period
  5. * English or Spanish speaking, willing, and capable of providing written informed consent
  1. * Has a planned concurrent surgical procedure (e.g. bilateral TKA) at the time of surgery or a planned surgical procedure before the last trial visit
  2. * Has had any previous open surgery, (e.g., ORIF for fracture, osteotomy, arthroplasty, unicompartmental knee arthroplasty, or TKA), in the trial knee at any time in the past or arthroscopic surgery within 12 months. Has had any previous surgery in the contralateral knee within 6 months prior to screening
  3. * Has been administered any type of intra-articular injection within 3 months of surgery in the trial knee
  4. * Unable to abstain from opioid use for knee pain (including codeine) within 2 weeks (14 days) of surgery
  5. * Has a Body Mass Index (BMI) ≥45 kg/m²
  6. * Is unwilling or unable to discontinue use of medications or products that can impact pain control from the Screening Visit until the last trial visit (e.g. cannabidiol (CBD) oil, Kratom)
  7. * 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 participant or confound the postsurgical assessments or might confound or interfere with the outcome of the trial
  8. * Has received/used an investigational drug, product, or device for a clinical trial within 30 days of screening. COVID-19 vaccines (approved or under emergency use authorization locally) are permitted if the participant is not in a clinical trial for the vaccine
  9. * Has a positive drug screen at the Screening Visit or on the day of surgery
  10. * Has participated in an ATX101 clinical trial
  11. * Pregnant, breastfeeding, or planning to become pregnant during the trial or before the last trial visit

Contacts and Locations

Principal Investigator

David Hewitt, MD
STUDY_DIRECTOR
Allay Therapeutics, Inc.

Study Locations (Sites)

Woodland International Research Group, LLC
Little Rock, Arkansas, 72211
United States
Phoenix Clinical Research
Tamarac, Florida, 33321
United States
Atlanta Centre for Medical Research
Atlanta, Georgia, 30331
United States
NextStage Clinical Research
Wichita, Kansas, 67214
United States
Chesapeake Research Group, LLC
Pasadena, Maryland, 21122
United States
First Surgical Hospital
Bellaire, Texas, 77401
United States
Legent Orthopedic Hospital
Carrollton, Texas, 75006
United States
Memorial Hermann Village
Houston, Texas, 77043
United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78240
United States
NextStage Clinical Research
San Antonio, Texas, 78258
United States
JBR Clinical Research, LLC
Salt Lake City, Utah, 84107
United States

Collaborators and Investigators

Sponsor: Allay Therapeutics, Inc.

  • David Hewitt, MD, STUDY_DIRECTOR, Allay Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03
Study Completion Date2025-10-03

Study Record Updates

Study Start Date2025-02-03
Study Completion Date2025-10-03

Terms related to this study

Keywords Provided by Researchers

  • postoperative pain
  • post-surgical pain total knee arthroplasty
  • bupivacaine
  • bupivacaine implant
  • total knee replacement
  • ATX101
  • TKA
  • post-operative pain
  • postsurgical pain
  • post-surgical pain
  • postsurgical pain total knee arthroplasty

Additional Relevant MeSH Terms

  • Total Knee Arthroplasty (Postoperative Pain)