[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658822":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":19,"studyPopulation":19,"armGroups":40,"interventions":54,"overallOfficials":19,"centralContacts":68,"locations":74,"responsibleParty":93,"collaborators":19,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":19,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":19,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":19,"overallStatus":77,"whyStopped":19,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"AmacaThera Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":19},[9],{"measure":10,"description":11,"timeFrame":12},"Safety and Tolerability of AMT-143","To evaluate the safety and tolerability of AMT-143 in participants undergoing unilateral bunionectomy.\n\nThe 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",[14,17,20,22,24,26,28],{"measure":15,"description":16,"timeFrame":12},"Analgesic Efficacy of AMT-143","To evaluate efficacy of AMT-143 for postsurgical pain management following unilateral bunionectomy.\n\nNumeric Rating Scale (NRS) pain intensity will be assessed while the participant is seated\u002Frecumbent 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.",{"measure":18,"description":19,"timeFrame":12},"Area under the plasma concentration-versus-time curve (AUC)",null,{"measure":21,"description":19,"timeFrame":12},"Maximum observed plasma concentration (Cmax)",{"measure":23,"description":19,"timeFrame":12},"Time of maximum observed plasma concentration (Tmax)",{"measure":25,"description":19,"timeFrame":12},"Apparent terminal elimination half-life (t1\u002F2)",{"measure":27,"description":19,"timeFrame":12},"Apparent clearance (CL)",{"measure":29,"description":19,"timeFrame":12},"Apparent volume of distribution (Vd)",{"allocation":31,"interventionModel":32,"interventionModelDescription":19,"primaryPurpose":33,"observationalModel":19,"timePerspective":19,"maskingInfo":34},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":35,"maskingDescription":19,"whoMasked":36},"TRIPLE",[37,38,39],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[41,46,49],{"label":42,"type":43,"description":19,"interventionNames":44},"AMT-143 Group 1","EXPERIMENTAL",[45],"Drug: AMT-143",{"label":47,"type":43,"description":19,"interventionNames":48},"AMT-143 Group 2",[45],{"label":50,"type":51,"description":19,"interventionNames":52},"Saline Placebo","PLACEBO_COMPARATOR",[53],"Other: Saline (NaCl 0,9 %) (placebo)",[55,60,63],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":19},"DRUG","AMT-143","Group 1 will receive AMT-143 containing 354 mg ropivacaine.",[42],{"type":56,"name":57,"description":61,"armGroupLabels":62,"otherNames":19},"Group 2 will receive AMT-143 containing 707 mg ropivacaine.",[47],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":19},"OTHER","Saline (NaCl 0,9 %) (placebo)","Group 3 will receive 2.00 mL Placebo \\[sodium chloride (NaCl) 0.9%\\].",[50],[69],{"name":70,"role":71,"phone":72,"phoneExt":19,"email":73},"Ab Khulbe","CONTACT","416-360-2094","ab@amacathera.ca",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Diex Reserche","RECRUITING","Sherbrooke","Quebec","J1E 0N8","Canada","CA",{"type":84,"coordinates":85},"Point",[86,87],-71.89908,45.40008,{"lat":87,"lon":86},[90],{"name":91,"role":71,"phone":92,"phoneExt":19,"email":19},"Pierre Arsenault","819-346-2887",{"type":94,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100658822","phase-2-postsurgical-analgesia-after-unilateral-bunionectomy-100658822",false,"NCT07858734","Postsurgical Analgesia After Unilateral Bunionectomy","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","Inclusion Criteria:\n\n1. Ability and willingness to provide written informed consent, adhere to the study visit schedule, and complete all study assessments.\n2. Adults 18 to 75 years at screening.\n3. Planned distal metaphyseal osteotomy procedure (e.g., Austin procedure\u002Fchevron osteotomy) under general anesthesia.\n4. Health surgery rating according to American Society of Anesthesiologists (ASA) class 1-3.\n5. Body mass index (BMI) ≥18 and ≤39 kg\u002Fm\\^2.\n\nExclusion Criteria:\n\n1. Surgery is for minimally invasive bunionectomy procedure.\n2. Contralateral bunionectomy within 3 months of study dosing.\n3. Planned surgical intervention concurrent with unilateral bunionectomy (e.g., collateral procedures).\n4. Hypersensitivity\u002Fallergy to any ingredient in AMT-143 formulation (hyaluronan or methylcellulose).\n5. History or presence of glucose-6-phosphate dehydrogenase deficiency.\n6. History or presence of congenital or idiopathic methemoglobinemia.\n7. Hypersensitivity\u002Fallergy to amide type local anaesthetics (e.g., lidocaine, bupivacaine, ropivacaine, etc.).\n8. Loss of sensation or significant peripheral neuropathy on the side of bunionectomy.\n9. 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.\n10. Arrhythmias predisposing to long QT syndrome (e.g., ventricular tachycardia, atrial fibrillation, atrioventricular block, etc.).\n11. 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:\n\n    * Myocardial infarction within 6 months of study dosing or coronary bypass grafting within 12 months of study dosing.\n    * Congestive heart failure (New York Heart Association Class III-IV).\n    * Uncontrolled diabetes with A1C hemoglobin ≥ 7%.\n    * Severe peripheral vascular disease.\n    * Pulmonary dysfunction.\n    * Severe hepatic or renal dysfunction.\n    * Coagulation or bleeding disorders.\n    * Uncontrolled anxiety, schizophrenia, or other psychiatric disorders.\n12. Have history of human immunodeficiency virus (HIV) or hepatitis B\u002Fhepatitis C or a positive test at screening.\n13. Suspected or known addiction or abuse of illicit drugs, prescription medications, or alcohol within 2 years of study.\n14. 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.\n15. 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.\n16. Current use of neuromodulating agents \\[e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta), etc.\\].\n17. Use of systemic glucocorticoids within 30 days of study dosing.\n18. Use of dexmedetomidine HCl (Precedex®) or clonidine within 3 days of study dosing.\n19. Chronic opioid use \\[average ≥30 oral morphine equivalents (OMEDs)\u002Fday\\] within 30 days of study dosing.\n20. Use of opioid medications within 3 days of study dosing.\n21. Use of marijuana, tetrahydrocannabinol (THC), and cannabidiol (CBD) within 30 days of study dosing or planned use during the course of the study.\n22. Current pregnancy, nursing, or planning to become pregnant during the study.\n23. Unwillingness to use effective methods of contraception during participation in this study (for females with childbearing potential and males).\n24. Recent or potential exposure to COVID-19.","ALL","18 Years","75 Years",{"count":106,"type":107},60,"ESTIMATED","INTERVENTIONAL",[110],"PHASE2","The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of two doses of AMT-143 in participants after unilateral bunionectomy.",[113,114],"Bunionectomy","Bunion","2026-10-01",{"date":117,"type":118},"2026-10-05","ACTUAL",{"date":120,"type":107},"2026-10-18",{"date":122,"type":107},"2027-06-15",{"name":5,"class":6},1]