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Drug

Bupivacaine + ATX-101 for Knee Surgery Pain (SPARK Trial)

Phase 2
Waitlist Available
Research Sponsored by Allay Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 30 minutes post-surgery through hour 168, hour 240, and hour 336
Awards & highlights

SPARK Trial Summary

This trial is testing a drug's safety and effectiveness to reduce pain after knee replacement surgery. SPARK: Study Assessing Pain Relief after Knee Replacement.

Who is the study for?
This trial is for adults with knee pain from osteoarthritis or post-traumatic arthritis, scheduled for total knee replacement surgery using a specific anesthesia technique. Participants should be in good to moderate health and not have had recent surgeries, local anesthetics, or certain medical conditions that could affect the study.Check my eligibility
What is being tested?
The SPARK study tests the safety and effectiveness of ATX-101 compared to bupivacaine hydrochloride (without epinephrine) for pain relief after knee replacement surgery. It's randomized and double-blind, meaning neither doctors nor patients know who gets which treatment.See study design
What are the potential side effects?
Possible side effects may include typical reactions to local anesthetics like numbness, weakness, backache, headache or dizziness. Since it's a test drug, ATX-101 might also have unknown risks that will be monitored during the trial.

SPARK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need a knee replacement due to arthritis pain.
Select...
I am scheduled for a knee replacement surgery without a drain, using specific anesthesia.
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I am in good to moderate health with or without severe systemic disease.

SPARK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 30 minutes post-surgery through hour 168, hour 240, and hour 336
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 30 minutes post-surgery through hour 168, hour 240, and hour 336 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Area under the curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of pain intensity.
Area under the curve for the Numeric Rating Scale at Rest (NRS-R) of pain intensity.
Percentage of subject who remain opioid free.
+4 more

Side effects data

From 2015 Phase 3 trial • 55 Patients • NCT02123134
71%
Injection site bruising
71%
Injection site pain
61%
Injection site swelling
50%
Injection site anaesthesia
29%
Injection site nodule
18%
Injection site oedema
14%
Injection site induration
14%
Injection site erythema
7%
Pain in jaw
7%
Dysphonia
7%
Skin tightness
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
ATX-101 (Deoxycholic Acid) Injection

SPARK Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: ATX-101 Dose BExperimental Treatment1 Intervention
ATX-101 Dose B
Group II: ATX-101 Dose AExperimental Treatment1 Intervention
ATX-101 Dose A
Group III: bupivacaine hydrochlorideActive Control1 Intervention
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATX-101
2008
Completed Phase 3
~330

Find a Location

Who is running the clinical trial?

Allay Therapeutics, Inc.Lead Sponsor

Media Library

ATX-101 (Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05260008 — Phase 2
Postoperative Pain Research Study Groups: bupivacaine hydrochloride, ATX-101 Dose B, ATX-101 Dose A
Postoperative Pain Clinical Trial 2023: ATX-101 Highlights & Side Effects. Trial Name: NCT05260008 — Phase 2
ATX-101 (Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05260008 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA ratified ATX-101 Dose B for therapeutic application?

"Our team at Power assigned ATX-101 Dose B a score of 2 on the safety scale as it is currently in Phase 2. Thus far, there exists some evidence that this intervention is safe but no data suggesting its efficacy."

Answered by AI

Do I fulfill the criteria to join this investigation?

"This clinical trial seeks to enroll 305 individuals aged 18-80 who are experiencing postoperative pain. In addition, these patients must have a primary indication of total knee arthroplasty due to osteoarthritis or posttraumatic arthritis and be classified according to the ASA Physical Classification System as either class 1, 2 or 3. They should also plan on undergoing unilateral total knee arthroplasty with cemented prosthesis without using a surgical drain and under bupivacaine spinal anesthesia (dextrose is allowed)."

Answered by AI

Are there still vacancies available for individuals to partake in this research?

"Affirmative. The clinical trial is actively searching for participants, as evidenced by the data on its page on clinicaltrials.gov which was last edited on June 9th 2023 after being initially posted a year prior in July 2022 and currently seeks to enrol 305 patients from nine sites."

Answered by AI

How many individuals are currently involved in this research?

"To conduct this trial, 305 participants with suitable inclusion criteria must be recruited. Allay Therapeutics, Inc., the sponsor of the study, has chosen to operate out of London Health Sciences Centre - University Hospital in London and Department of Trauma and Orthopaedic Surgery at Addenbrooke's Hospital in Cambridge as two sites."

Answered by AI

Is this trial recruiting individuals of advanced age?

"The eligibility requirements for this study state that participants must be within the age range of 18 to 80."

Answered by AI

What is the geographic scope of this scientific inquiry?

"The current study is being conducted at London Health Sciences Centre - University Hospital in London, Department of Trauma and Orthopaedic Surgery, Addenbrooke's Hospital in Cambridge, Royal National Orthopaedic Hospital in Stanmore as well as other 9 locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Assessing Pain Relief After Replacement of the Knee
2022. "Study Assessing Pain Relief After Replacement of the Knee". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05260008.
~128 spots leftby Aug 2025
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