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Study Assessing Pain Relief After Replacement of the Knee (SPARK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05260008
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Allay Therapeutics, Inc.

Study Description
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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)

Condition or disease Intervention/treatment Phase
Acute Postoperative Pain Drug: ATX-101 Drug: bupivacaine hydrochloride without epinephrine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Phase 2B, randomized, double blind, active comparator multicenter trial in participants undergoing total knee arthroplasty.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty
Actual Study Start Date : June 7, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ATX-101 Dose A
ATX-101 Dose A
 Drug: ATX-101
ATX-101 (bupivacaine) implant, one-time administration into the surgical site
Experimental: ATX-101 Dose B
ATX-101 Dose B
 Drug: ATX-101
ATX-101 (bupivacaine) implant, one-time administration into the surgical site
Active Comparator: bupivacaine hydrochloride
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block
 Drug: bupivacaine hydrochloride without epinephrine
bupivacaine hydrochloride (125 mg) without epinephrine via local infiltration and/or nerve block


Outcome Measures
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Primary Outcome Measures :
  1. Area under the curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of pain intensity. [ Time Frame: from 30 minutes post-surgery through hour 168 ]

Secondary Outcome Measures :
  1. Area under the curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of pain intensity. [ Time Frame: from 30 Minutes post-surgery through Hour 168, Hour 240, and Hour 336 ]
  2. Percentage of subjects who remain opioid free. [ Time Frame: from Hour 72 post-surgery through Day 30 ]
  3. Total post-surgical consumption of opioid medications. [ Time Frame: from surgical closure through Day 30 ]
  4. Area under the curve for the Numeric Rating Scale at Rest (NRS-R) of pain intensity. [ Time Frame: from surgical closure for each 24-hour period through Hour 336 ]
  5. Percentage of subject who remain opioid free. [ Time Frame: Surgical Closure to Day 30 ]
  6. Total post-surgical use of rescue opioid medications. [ Time Frame: Surgical Closure to Day 30 ]
  7. Time to first postsurgical use of rescue opioid medication. [ Time Frame: Surgical Closure to Day 30 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) ≥40 kg/m2.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05260008


Locations
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Australia, New South Wales
Prince of Wales Private Hospital Terminated
Sydney, New South Wales, Australia, 2031
Australia, Queensland
John Flynn Private Hospital Recruiting
Tugun, Queensland, Australia, 4224
Contact: Emily Vasiljevski    +61 (07) 5598-9733    Vasiljevskie@ramsayhealth.com.au   
Australia, South Australia
Royal Adelaide Hospital / PARC Clinical Research Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Kathy Heyman    +61 (08) 7074 4404    kathy.heyman2@sa.gov.au   
Australia, Victoria
The Avenue Private Hospital Recruiting
Windsor, Victoria, Australia, 3181
Contact: Nicky Dalgleish    +61 (03) 9526-5439    DalgleishN@ramsayhealth.com.au   
United Kingdom
Chapel Allerton Hospital C/O The Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, West Yorkshire, United Kingdom, LS7 4SA
Contact: Gary Lockley-Ault    +44 (0)113 392 4729    gary.lockley-ault@nhs.net   
Sponsors and Collaborators
Allay Therapeutics, Inc.
More Information
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Responsible Party: Allay Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05260008    
Other Study ID Numbers: ATX-101-TKA-003
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Allay Therapeutics, Inc.:
postoperative pain
post-surgical pain total knee arthroplasty
total knee replacement ATX-101
bupivacaine
bupivacaine implant
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Epinephrine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
 Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents