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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05260008




Registration number
NCT05260008
Ethics application status
Date submitted
18/02/2022
Date registered
2/03/2022

Titles & IDs
Public title
Study Assessing Pain Relief After Replacement of the Knee
Scientific title
A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty
Secondary ID [1] 0 0
ATX-101-TKA-003
Universal Trial Number (UTN)
Trial acronym
SPARK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Postoperative Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ATX-101
Treatment: Drugs - ATX-101
Treatment: Drugs - bupivacaine hydrochloride without epinephrine

Experimental: ATX-101 Dose A - ATX-101 Dose A

Experimental: ATX-101 Dose B - ATX-101 Dose B

Active comparator: bupivacaine hydrochloride - bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block


Treatment: Drugs: ATX-101
ATX-101 (bupivacaine) implant, one-time administration into the surgical site

Treatment: Drugs: ATX-101
ATX-101 (bupivacaine) implant, one-time administration into the surgical site

Treatment: Drugs: bupivacaine hydrochloride without epinephrine
bupivacaine hydrochloride (125 mg) without epinephrine via local infiltration and/or nerve block
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of pain intensity.
Timepoint [1] 0 0
from 30 minutes post-surgery through hour 168
Secondary outcome [1] 0 0
Area under the curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of pain intensity.
Timepoint [1] 0 0
from 30 Minutes post-surgery through Hour 168, Hour 240, and Hour 336
Secondary outcome [2] 0 0
Percentage of subjects who remain opioid free.
Timepoint [2] 0 0
from Hour 72 post-surgery through Day 30
Secondary outcome [3] 0 0
Total post-surgical consumption of opioid medications.
Timepoint [3] 0 0
from surgical closure through Day 30
Secondary outcome [4] 0 0
Area under the curve for the Numeric Rating Scale at Rest (NRS-R) of pain intensity.
Timepoint [4] 0 0
from surgical closure for each 24-hour period through Hour 336
Secondary outcome [5] 0 0
Percentage of subject who remain opioid free.
Timepoint [5] 0 0
Surgical Closure to Day 30
Secondary outcome [6] 0 0
Total post-surgical use of rescue opioid medications.
Timepoint [6] 0 0
Surgical Closure to Day 30
Secondary outcome [7] 0 0
Time to first postsurgical use of rescue opioid medication.
Timepoint [7] 0 0
Surgical Closure to Day 30

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/01/2024
Sample size
Target
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Prince of Wales Private Hospital - Sydney
Recruitment hospital [2] 0 0
John Flynn Private Hospital - Tugun
Recruitment hospital [3] 0 0
Royal Adelaide Hospital / PARC Clinical Research - Adelaide
Recruitment hospital [4] 0 0
St Andrew's Private Hospital - Adelaide
Recruitment hospital [5] 0 0
The Avenue Private Hospital - Windsor
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
4224 - Tugun
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3181 - Windsor
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Cambridgeshire
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Hampshire
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Middlesex
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Nottinghamshire
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Shropshire
Country [7] 0 0
United Kingdom
State/province [7] 0 0
West Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allay Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05260008