Clinical trial NCT06799845: Study Assessing Pain Relief After Replacement of the Knee
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Total Knee Arthroplasty (Postoperative Pain)
Keywords: 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
Lead sponsor: Allay Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Area under the curve (AUC) for the Numerical Rating Scale at Rest (NRS-R) of pain intensity
timeFrame: from 30 minutes through 168 hours (Day 8) compared to placebo
Secondary outcomes:
measure: AUC for the NRS-R of pain intensity
timeFrame: 30 minutes through 336 hours (Day 15) compared to placebo
measure: AUC for the NRS-R of pain intensity
timeFrame: from 30 minutes through 504 hours (Day 22) compared to placebo
measure: Total post-surgical consumption of opioid medications
timeFrame: from 30 minutes through 336 hours (Day 15) compared to placebo
measure: AUC for the NRS-R of pain intensity
timeFrame: from 30 minutes through 336 hours (Day 15) compared to active comparator
measure: Difference in NRS-A pain intensity scores during the Timed Up and Go (TUG) Test
timeFrame: at Day 15 compared to placebo
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group, LLC
state: Arkansas
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
city: Tamarac
country: United States
facility: Phoenix Clinical Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Centre for Medical Research
state: Georgia
city: Wichita
country: United States
facility: NextStage Clinical Research
state: Kansas
city: Pasadena
country: United States
facility: Chesapeake Research Group, LLC
state: Maryland
city: Bellaire
country: United States
facility: First Surgical Hospital
state: Texas
city: Carrollton
country: United States
facility: Legent Orthopedic Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Village
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: NextStage Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research, LLC
state: Utah
Study officials:
affiliation: Allay Therapeutics, Inc.
name: David Hewitt, MD
role: STUDY_DIRECTOR
References: