Postsurgical Analgesia After Unilateral Bunionectomy

October 20, 2026 updated by: AmacaThera Inc.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of AMT-143 for Postsurgical Analgesia After Unilateral Bunionectomy

The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of two doses of AMT-143 in participants after unilateral bunionectomy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ability and willingness to provide written informed consent, adhere to the study visit schedule, and complete all study assessments.
  2. Adults 18 to 75 years at screening.
  3. Planned distal metaphyseal osteotomy procedure (e.g., Austin procedure/chevron osteotomy) under general anesthesia.
  4. Health surgery rating according to American Society of Anesthesiologists (ASA) class 1-3.
  5. Body mass index (BMI) ≥18 and ≤39 kg/m^2.

Exclusion Criteria:

  1. Surgery is for minimally invasive bunionectomy procedure.

  2. Contralateral bunionectomy within 3 months of study dosing.

  3. Planned surgical intervention concurrent with unilateral bunionectomy (e.g., collateral procedures).

  4. Hypersensitivity/allergy to any ingredient in AMT-143 formulation (hyaluronan or methylcellulose).

  5. History or presence of glucose-6-phosphate dehydrogenase deficiency.

  6. History or presence of congenital or idiopathic methemoglobinemia.

  7. Hypersensitivity/allergy to amide type local anaesthetics (e.g., lidocaine, bupivacaine, ropivacaine, etc.).

  8. Loss of sensation or significant peripheral neuropathy on the side of bunionectomy.

  9. Concurrent pain syndromes (e.g., arthritis, fibromyalgia, cancer, etc.) that would require an additional use of non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or opioids during the course of the study.

  10. Arrhythmias predisposing to long QT syndrome (e.g., ventricular tachycardia, atrial fibrillation, atrioventricular block, etc.).

  11. Disease or condition that in the opinion of the Investigator, would pose a health risk to the participant or interfere with study assessments or compliance, including but not limited to, any of the following:

    • Myocardial infarction within 6 months of study dosing or coronary bypass grafting within 12 months of study dosing.
    • Congestive heart failure (New York Heart Association Class III-IV).
    • Uncontrolled diabetes with A1C hemoglobin ≥ 7%.
    • Severe peripheral vascular disease.
    • Pulmonary dysfunction.
    • Severe hepatic or renal dysfunction.
    • Coagulation or bleeding disorders.
    • Uncontrolled anxiety, schizophrenia, or other psychiatric disorders.

  12. Have history of human immunodeficiency virus (HIV) or hepatitis B/hepatitis C or a positive test at screening.

  13. Suspected or known addiction or abuse of illicit drugs, prescription medications, or alcohol within 2 years of study.

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

  15. Administration of medications with a potential for drug interactions with ropivacaine (i.e., amide-type local anaesthetics such as lidocaine, bupivacaine, mepivacaine and prilocaine; antiarrhythmics such as procainamide, disopyramide, tocainide, mexiletine and flecainide; inhibitors of cytochrome P4501A2 such as fluvoxamine and enoxacin) for at least 5 half-lives prior to study dosing.

  16. Current use of neuromodulating agents [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta), etc.].

  17. Use of systemic glucocorticoids within 30 days of study dosing.

  18. Use of dexmedetomidine HCl (Precedex®) or clonidine within 3 days of study dosing.

  19. Chronic opioid use [average ≥30 oral morphine equivalents (OMEDs)/day] within 30 days of study dosing.

  20. Use of opioid medications within 3 days of study dosing.

  21. Use of marijuana, tetrahydrocannabinol (THC), and cannabidiol (CBD) within 30 days of study dosing or planned use during the course of the study.

  22. Current pregnancy, nursing, or planning to become pregnant during the study.

  23. Unwillingness to use effective methods of contraception during participation in this study (for females with childbearing potential and males).

  24. Recent or potential exposure to COVID-19.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Saline Placebo
Other: Saline (NaCl 0,9 %) (placebo)

Group 3 will receive 2.00 mL Placebo [sodium chloride (NaCl) 0.9%].
Experimental: AMT-143 Group 1
Drug: AMT-143

Group 1 will receive AMT-143 containing 354 mg ropivacaine.

Drug: AMT-143

Group 2 will receive AMT-143 containing 707 mg ropivacaine.
Experimental: AMT-143 Group 2
Drug: AMT-143

Group 1 will receive AMT-143 containing 354 mg ropivacaine.

Drug: AMT-143

Group 2 will receive AMT-143 containing 707 mg ropivacaine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of AMT-143
Time Frame: From surgery to Day 28 follow-up

To evaluate the safety and tolerability of AMT-143 in participants undergoing unilateral bunionectomy.

The primary safety endpoint is the incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) which reflect manifestations of local anesthetic (ropivacaine) systemic toxicity (LAST).
From surgery to Day 28 follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analgesic Efficacy of AMT-143
Time Frame: From surgery to Day 28 follow-up

To evaluate efficacy of AMT-143 for postsurgical pain management following unilateral bunionectomy.

Numeric Rating Scale (NRS) pain intensity will be assessed while the participant is seated/recumbent with the surgically attended leg elevated or lying supine. The participant will be asked to rate their pain intensity on a scale of 0 to 10, where 0 = no pain and 10 = worst pain.
From surgery to Day 28 follow-up
Area under the plasma concentration-versus-time curve (AUC)
Time Frame: From surgery to Day 28 follow-up
From surgery to Day 28 follow-up
Maximum observed plasma concentration (Cmax)
Time Frame: From surgery to Day 28 follow-up
From surgery to Day 28 follow-up
Time of maximum observed plasma concentration (Tmax)
Time Frame: From surgery to Day 28 follow-up
From surgery to Day 28 follow-up
Apparent terminal elimination half-life (t1/2)
Time Frame: From surgery to Day 28 follow-up
From surgery to Day 28 follow-up
Apparent clearance (CL)
Time Frame: From surgery to Day 28 follow-up
From surgery to Day 28 follow-up
Apparent volume of distribution (Vd)
Time Frame: From surgery to Day 28 follow-up
From surgery to Day 28 follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AmacaThera Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMT-143-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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