Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
Recruiting
Phase 2
Interventional Study
Hallux Valgus
Bunionectomy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Rebel Medicine Inc · Industry
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Contacts