A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty

Allay Therapeutics, Inc.13 sites in 3 countries112 target enrollmentJune 7, 2022

ConditionsAcute Postoperative Pain

InterventionsATX-101 bupivacaine hydrochloride without epinephrine

Overview

Phase: Phase 2
Intervention: ATX-101
Conditions: Acute Postoperative Pain
Sponsor: Allay Therapeutics, Inc.
Enrollment: 112
Locations: 13
Primary Endpoint: Area Under the Curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of Pain Intensity.
Status: Terminated
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

June 7, 2022

End Date

January 15, 2024

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allay Therapeutics, Inc.

Responsible Party

Sponsor

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.

Arms & Interventions

ATX-101 Dose A

Intervention: ATX-101

ATX-101 Dose B

Intervention: ATX-101

bupivacaine hydrochloride

bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block

Intervention: bupivacaine hydrochloride without epinephrine

Outcomes

Primary Outcomes

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 (Day 8)

NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10).

Secondary Outcomes

Percentage of Subject Who Remain Opioid Free.(Surgical Closure to Day 30)
Time to First Rescue Opioid Medication.(Surgical Closure to Day 30)
Total Post-surgical Use of Rescue Opioid Medications.(Surgical Closure to Day 30, Opioid consumption is summarized descriptively every 24-hour period through Day 30)