Actively Recruiting
A Phase 2, Randomized, Double-blind, Active-controlled, Dose-escalation Study to Evaluate ALX006 for Postsurgical Pain Management Using Sciatic Nerve Block in Bunionectomy Subjects
Led by Rebel Medicine Inc · Updated on 2026-05-07
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ALX006, an extended-release bupivacaine formulation, for managing postsurgical pain in adults undergoing primary unilateral bunionectomy. This Phase 2, randomized, double-blind, active-controlled, dose-escalation study aims to assess the safety, pharmacokinetics, efficacy, and pharmacodynamics of ALX006 compared to MARCAINE 0.25% (bupivacaine HCl). Approximately 60 participants will be enrolled across three dose groups, with dose escalation guided by an Independent Data Monitoring Committee. Participants will receive a single ultrasound-guided sciatic nerve block in the popliteal fossa about 60 minutes before surgery. The study includes three ALX006 dose levels—100 mg, 150 mg, and 200 mg—and an active comparator group receiving 50 mg MARCAINE 0.25%. The treatments are administered once, and participants are randomly assigned in a 3:1 ratio to ALX006 or MARCAINE within each dose cohort. Throughout the study, participants will be monitored for treatment-emergent adverse events up to 15 days after the nerve block. Pain intensity and opioid consumption will be assessed for up to 120 hours after surgery using numeric rating scales and opioid use measurements. Blood samples will be taken to study bupivacaine levels over 168 hours after administration. Participants are expected to attend follow-up visits and complete assessments according to the study schedule, which includes ongoing safety and pharmacologic monitoring.
CONDITIONS
Brief Title
Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, ages 18 or older at screening
- Physical health status classified as American Society of Anesthesiologists (ASA) 1, 2, or 3
- Able to provide informed consent and complete all study assessments
- Scheduled for primary unilateral distal metaphyseal osteotomy bunionectomy surgery
- Elective (non-emergency) bunionectomy planned
- Body Mass Index (BMI) between 18 and less than 40 kg/m2
You will not qualify if you...
- Allergy or intolerance to study medications including local anesthetics, opioids, or NSAIDs without alternative options
- Painful conditions like arthritis or fibromyalgia requiring pain treatment unrelated to surgery
- Poor sensory function in foot or ankle
- History or current addiction to drugs, prescription medicines, or alcohol within past 2 years
- Use of investigational drugs within 30 days or five elimination half-lives prior to study
- Local anesthetic use within 72 hours before study drug administration except for pretreatment
- Need for additional local anesthetic besides study drug or lidocaine during study
- Uncontrolled anxiety, psychiatric, or neurological disorders affecting study compliance
- Pregnant, nursing, or planning pregnancy during study
- Significant medical diseases making study participation inappropriate
- Vital sign or ECG abnormalities including QTcF > 450 msec
- Liver cirrhosis or elevated liver enzymes above 3 times upper limit of normal
- Severe kidney impairment or dialysis
- Low platelet count, hemoglobin, or hematocrit levels
- Use of gabapentinoids or certain serotonin-norepinephrine reuptake inhibitors that cannot be stopped 30 days before surgery
- Systemic glucocorticoid use within 30 days of randomization
- Use of dexmedetomidine or clonidine within 3 days of study drug
- Marijuana use within 30 days prior or planned during study
- Chronic opioid use averaging 30 mg or more oral morphine equivalents per day within 30 days prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (day of surgery)
Participants receive a single-dose ultrasound-guided sciatic nerve block with ALX006 or bupivacaine approximately 60 minutes prior to bunionectomy surgery to manage postsurgical pain.
1 visit (in-person)
Duration - Up to 15 days post-surgery
Participants are monitored for safety and pain management outcomes for up to 15 days after the nerve block procedure.
Multiple visits through Day 15
Trial Site Locations
Total: 1 location
1
CenExel Salt Lake City
Millcreek, Utah, United States, 84107
Actively Recruiting
Research Team
C
Caleb Lade, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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