Evaluating Pain Relief After Knee Replacement
A Phase 2B, Randomized, Double Blind, Placebo and Active Comparator Controlled, Multicenter, Safety, and Efficacy Trial of ATX101 in Adults Undergoing Total Knee Arthroplasty
This study is testing a new pain relief medication called ATX101 to see if it helps people feel better after knee replacement surgery compared to a placebo and a standard pain drug.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Allay Therapeutics, Inc. Industry-sponsored |
| Locations | 13 sites (Little Rock, Arkansas and 12 other locations) |
| Trial ID | NCT06799845 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of ATX101, a pain relief medication, in patients undergoing primary unilateral total knee arthroplasty. Participants will be randomly assigned to receive either ATX101, a saline placebo, or bupivacaine, an established pain management drug. The study will also monitor opioid consumption and evaluate the safety and tolerability of ATX101 compared to the other treatments. The trial is designed to provide insights into postoperative pain management for knee replacement surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for primary unilateral total knee arthroplasty due to knee pain from osteoarthritis or post-traumatic arthritis.
Not a fit: Patients who have planned concurrent surgical procedures or previous surgeries on the trial knee may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing knee replacement surgery.
How similar studies have performed: Other studies have shown promising results with similar approaches to postoperative pain management, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Primary indication of TKA is knee pain due to osteoarthritis or post-traumatic arthritis * Scheduled to undergo primary unilateral TKA 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 * 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 * English or Spanish speaking, willing, and capable of providing written informed consent Key Exclusion Criteria: * 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 * 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 * Has been administered any type of intra-articular injection within 3 months of surgery in the trial knee * Unable to abstain from opioid use for knee pain (including codeine) within 2 weeks (14 days) of surgery * Has a Body Mass Index (BMI) ≥45 kg/m² * 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) * 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 * 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 * Has a positive drug screen at the Screening Visit or on the day of surgery * Has participated in an ATX101 clinical trial * Pregnant, breastfeeding, or planning to become pregnant during the trial or before the last trial visit Other protocol defined Inclusion/Exclusion criteria may apply
Where this trial is running
Little Rock, Arkansas and 12 other locations
- Woodland International Research Group, LLC — Little Rock, Arkansas, United States (Recruiting)
- Clinical Pharmacology of Miami, LLC — Miami, Florida, United States (Recruiting)
- Phoenix Clinical Research — Tamarac, Florida, United States (Recruiting)
- ForCare Clinical Research — Tampa, Florida, United States (Withdrawn)
- Atlanta Centre for Medical Research — Atlanta, Georgia, United States (Recruiting)
- NextStage Clinical Research — Wichita, Kansas, United States (Recruiting)
- Chesapeake Research Group, LLC — Pasadena, Maryland, United States (Recruiting)
- First Surgical Hospital — Bellaire, Texas, United States (Recruiting)
- Legent Orthopedic Hospital — Carrollton, Texas, United States (Recruiting)
- Memorial Hermann Village — Houston, Texas, United States (Recruiting)
- Endeavor Clinical Trials, LLC — San Antonio, Texas, United States (Recruiting)
- NextStage Clinical Research — San Antonio, Texas, United States (Recruiting)
- JBR Clinical Research, LLC — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trial Lead
- Email: clinicaltrialsinfo@allaytx.com
- Phone: 669-679-5081
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.