Postoperative pain relief after bunion surgery with AMT-143
Official title: 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
Run by AmacaThera Inc. · NCT07858734 · Data updated 2026-11-12
This study tests two doses of AMT-143 to see if it helps reduce pain after unilateral bunionectomy in adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | AmacaThera Inc. Industry-sponsored |
| Locations | 1 site (Sherbrooke, Quebec) |
| Status | Recruiting |
| Started | November 1, 2026 |
| Main results expected | April 15, 2027 |
| Study ends | June 15, 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07858734 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 undergoing unilateral bunionectomy with ASA class 1-3 and a planned distal metatarsal osteotomy.
✕Probably not a fit
Patients with minimally invasive bunionectomy, contraindications to AMT-143 ingredients, or certain blood/metabolic conditions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2, interventional trial evaluates the safety, efficacy, and pharmacokinetics of two dose levels of AMT-143 compared with saline placebo in adults undergoing a unilateral bunionectomy. Participants receive AMT-143 or placebo during the postoperative period and are monitored for pain relief, safety signals, and how the drug behaves in the body. The study uses a randomized design with standard anesthesia and postoperative care, aiming to identify an effective dose with acceptable safety. Recruitment is limited to adults 18 to 75 with ASA 1-3 and a planned distal metatarsal osteotomy. The trial is conducted at a single site in Sherbrooke, Quebec, sponsored by AmacaThera Inc.
Why it matters
Potential benefit: If successful, AMT-143 could provide improved postoperative pain control after bunion surgery.
How similar studies have gone: Previous similarly designed analgesia trials with AMT-143-like approaches have shown potential in early phases, but this specific regimen is novel for bunionectomy pain.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Diex Reserche
Sherbrooke, Quebec, Canada Recruiting
Study contacts
- Study coordinator: Ab Khulbe
- Email: ab@amacathera.ca
- Phone: 416-360-2094
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.