Is NCT07574385 recruiting in Millcreek, UT?

Yes, NCT07574385 is currently recruiting participants at its Millcreek, UT location. This hallux valgus clinical trial is actively enrolling qualified participants.

How do I join the hallux valgus clinical trial in Millcreek?

To join this clinical trial in Millcreek, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Millcreek clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Hallux Valgus Clinical Trial in Millcreek, UT

About This Hallux Valgus Study in Millcreek

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.

Sponsor: Rebel Medicine Inc

Who Can Participate

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 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)

Indicated to undergo elective (i.e., not emergency) bunionectomy

Body Mass Index (BMI) ≥18 and \<40 kg/m2

Exclusion Criteria

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

Administration of an investigational drug within thirty (30) days or five (5) elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study

Administration of any local anesthetic within 72 hours prior to administration of study drug, other than for pretreatment prior to a needle placement

Require additional local anesthetic other than study drug or lidocaine used for the Mayo field block or for pretreatment prior to a needle placement during the study period

Uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance

Currently pregnant, nursing, or planning to become pregnant during the study

Clinically significant medical disease that, in the opinion of the Investigator would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction, glucose-6-phosphate dehydrogenase deficiency or other conditions that would constitute a contraindication to participation in the study

Confirmed clinically significant vital sign or ECG abnormality, including QTcF \> 450 msec at Screening

Has any of the following laboratory abnormalities during Screening (1 retest permitted):

History of liver cirrhosis, having an aspartate aminotransferase \>3x the upper limit of normal (ULN), or having an alanine aminotransferase \> 3x ULN.

Severe kidney function impairment as defined by estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation \<30 mL/min/1.73 m²or on dialysis.

Platelet count \< 100,000/uL, hemoglobin \< 12 g/dL, or hematocrit \< 35%.

Currently on a gabapentinoid (e.g., gabapentin, pregabalin \[Lyrica\]) or a serotonin-norepinephrine reuptake inhibitor (SNRI) with recognized analgesic properties (e.g., duloxetine \[Cymbalta\]) that cannot be discontinued within 30 days before surgery. Other agents with documented efficacy in modulating acute or chronic pain may be excluded at the discretion of the Investigator in consultation with the Sponsor Medical Monitor. Selective serotonin reuptake inhibitors (SSRIs) are not excluded under this criterion.

Current use of systemic glucocorticoids within thirty (30) days of randomization in this study

Use of dexmedetomidine HCl or clonidine within three (3) days of study drug administration

Any use of marijuana (including tetrahydrocannabinol (THC) and cannabidiol (CBD)) within thirty (30) days prior to randomization, or planned use during the study.

Chronic opioid use within thirty (30) days prior to randomization (average ≥30 oral morphine mg equivalents/day)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Millcreek?

Yes, this clinical trial (NCT07574385) has an active research site in Millcreek, UT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hallux Valgus Treatment Options in Millcreek, UT

If you're searching for hallux valgus treatment options in Millcreek, UT, this clinical trial (NCT07574385) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Millcreek research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hallux valgus specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hallux valgus clinical trials near you to find additional studies recruiting in your area.

Hallux Valgus Clinical Trial in Millcreek, UT

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