Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRebel Medicine Inc
About this trial
This is a Phase 2, randomized, double-blind, active-controlled, dose-escalation study evaluating the safety, pharmacokinetics, efficacy, and pharmacodynamics of ALX006, an extended-release bupivacaine formulation, administered as a single-dose sciatic nerve block in the popliteal fossa in adult subjects undergoing primary unilateral bunionectomy. Approximately 60 subjects will be enrolled across 3 sequential dose cohorts (100 mg, 150 mg, 200 mg ALX006), with each cohort comparing ALX006 against MARCAINE 0.25% (bupivacaine HCl 50 mg) as the active comparator at a 3:1 randomization ratio. Dose escalation between cohorts is governed by an Independent Data Monitoring Committee.
Eligibility criteria
Qualifiers
Male or female, ages 18 or older at screening
American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 (see Appendix 5)
Able to provide informed consent, adhere to the study schedule, and complete all study assessments
Primary surgical indication is related to a bunion deformity (i.e., hallux valgus) and subject is scheduled to undergo a primary unilateral distal metaphyseal osteotomy procedure (i.e., Austin procedure)
Disqualifiers
Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the surgery and which, in the Investigator's opinion, may confound the post dosing assessments
Inadequate sensory function of the foot/ankle as assessed by the Investigator
History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two (2) years
Trial design
Treatments tested in this trial
- ALX006 (bupivacaine extended-release injection)
- Bupivacaine Hcl 0.25% Inj
- Sciatic Nerve Block
Treatment groups
60 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov