Clinical trial NCT05260008: Study Assessing Pain Relief After Replacement of the Knee
Official title: A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Postoperative Pain
Keywords: postoperative pain
post-surgical pain total knee arthroplasty
total knee replacement ATX-101
bupivacaine
bupivacaine implant
Lead sponsor: Allay Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase 2B, randomized, double blind, active comparator multicenter trial in participants undergoing total knee arthroplasty.
Primary purpose: TREATMENT

Brief summary: This is a Phase 2B randomized, double blind, active controlled, multi-center clinical trial to evaluate the safety and efficacy of ATX-101 in participants following total knee arthroplasty. The following is short title and acronym for the study: Study Assessing Pain Relief after Replacement of the Knee (SPARK)


Eligibility 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 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) ≥45 kg/m2

Primary outcomes:
measure: Area under the curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of pain intensity.
timeFrame: from 30 minutes post-surgery through hour 168
Secondary outcomes:
measure: Area under the curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of pain intensity.
timeFrame: from 30 Minutes post-surgery through Hour 168, Hour 240, and Hour 336
measure: Percentage of subjects who remain opioid free.
timeFrame: from Hour 72 post-surgery through Day 30
measure: Total post-surgical consumption of opioid medications.
timeFrame: from surgical closure through Day 30
measure: Area under the curve for the Numeric Rating Scale at Rest (NRS-R) of pain intensity.
timeFrame: from surgical closure for each 24-hour period through Hour 336
measure: Percentage of subject who remain opioid free.
timeFrame: Surgical Closure to Day 30
measure: Total post-surgical use of rescue opioid medications.
timeFrame: Surgical Closure to Day 30
measure: Time to first postsurgical use of rescue opioid medication.
timeFrame: Surgical Closure to Day 30
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Prince of Wales Private Hospital
state: New South Wales
city: Tugun
country: Australia
facility: John Flynn Private Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital / PARC Clinical Research
state: South Australia
city: Adelaide
country: Australia
facility: St Andrew's Private Hospital
state: South Australia
city: Windsor
country: Australia
facility: The Avenue Private Hospital
state: Victoria
city: Ajax
country: Canada
facility: Durham Bone and Joint Specialists
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Cambridge
country: United Kingdom
facility: Department of Trauma and Orthopaedic Surgery, Addenbrooke's Hospital
state: Cambridgeshire
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital
state: Middlesex
city: Nottingham
country: United Kingdom
facility: Nottingham Elective Orthopaedic Service, Nottingham University Hospitals
state: Nottinghamshire
city: Oswestry
country: United Kingdom
facility: Robert Jones & Agnes Hunt Orthopaedic Hospital
state: Shropshire
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital C/O The Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
Study officials:
References: