ATX101 for Postoperative Pain (SPARK 2 Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Allay Therapeutics, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of the ATX101-TKA-004 clinical trial aims to evaluate the efficacy and safety of ATX101 1,500 mg in participants undergoing primary unilateral total knee arthroplasty. The study will compare the effectiveness of ATX101 with a saline placebo and bupivacaine, an active comparator. Additionally, it will assess opioid consumption among participants receiving ATX101 versus those given the saline placebo and bupivacaine. The trial will also focus on the safety and tolerability of ATX101 in the participants.

Eligibility Criteria

This trial is for individuals undergoing primary unilateral total knee arthroplasty (knee replacement surgery) to assess pain relief. Participants must meet certain health criteria, which are not specified here.

Inclusion Criteria

I speak English or Spanish and can sign a consent form.

I am scheduled for a knee replacement with specific conditions.

I need a knee replacement due to arthritis pain.

My health is good to moderately impaired according to the ASA classification.

Exclusion Criteria

I have had knee surgery on the same or opposite knee within the past year.

I cannot stop taking opioids for knee pain 2 weeks before surgery.

I can stop using products like CBD oil that affect pain control for the trial duration.

Participant Groups

The study tests the effectiveness and safety of a drug called ATX101 (1,500 mg) compared to a saline placebo and bupivacaine hydrochloride, an established pain reliever. It also measures opioid use post-surgery among participants.

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: ATX101Experimental Treatment1 Intervention

Group II: bupivacaine hydrochlorideActive Control1 Intervention

Group III: saline placeboPlacebo Group1 Intervention