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Study Assessing Pain Relief After Replacement of the Knee

NCT05260008 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-08-14

Study results available
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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)

Conditions

  • Acute Postoperative Pain

Interventions

DRUG

ATX-101

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

DRUG

ATX-101

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

DRUG

bupivacaine hydrochloride without epinephrine

bupivacaine hydrochloride (125 mg) without epinephrine via local infiltration and/or nerve block

Sponsors & Collaborators

  • Allay Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2024-01-15
Completion
2024-01-15
FDA Drug
Yes

Countries

  • Australia
  • Canada
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05260008 on ClinicalTrials.gov