Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2025-01-27
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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AMT-143
AMT-143
AMT-143 is provided as a hydrogel containing 385 mg/mL ropivacaine (on a ropivacaine hydrochloride equivalence basis).
Participants undergoing primary open hernia repair, will be randomized to one of three treatment cohorts of escalating doses of AMT-143 hydrogel:
* Cohort 1: 1 mL AMT-143 hydrogel
* Cohort 2: 2 mL AMT-143 hydrogel
* Cohort 3: 3 mL AMT-143 hydrogel
Saline Placebo
Saline (NaCl 0,9 %) (placebo)
Saline placebo will consist of 0.9% sodium chloride injection USP and will be administered in an amount matching the volume of AMT-143 to be used in each of the Cohorts 1 to 3.
Ropivacaine solution
ropivacaine
The active comparator, ropivacaine hydrochloride 1% solution will be administered at a volume of 5 mL (50 mg) for all 3 cohorts.
Interventions
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AMT-143
AMT-143 is provided as a hydrogel containing 385 mg/mL ropivacaine (on a ropivacaine hydrochloride equivalence basis).
Participants undergoing primary open hernia repair, will be randomized to one of three treatment cohorts of escalating doses of AMT-143 hydrogel:
* Cohort 1: 1 mL AMT-143 hydrogel
* Cohort 2: 2 mL AMT-143 hydrogel
* Cohort 3: 3 mL AMT-143 hydrogel
Saline (NaCl 0,9 %) (placebo)
Saline placebo will consist of 0.9% sodium chloride injection USP and will be administered in an amount matching the volume of AMT-143 to be used in each of the Cohorts 1 to 3.
ropivacaine
The active comparator, ropivacaine hydrochloride 1% solution will be administered at a volume of 5 mL (50 mg) for all 3 cohorts.
Eligibility Criteria
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Inclusion Criteria
2. Participants are ≥18 years of age at screening.
3. Scheduled to undergo unilateral open inguinal hernia repair.
4. Body mass index (BMI) ≤40.0 kg/m2.
5. Male participants must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 1 week after the administration of study medication.
6. Female participants:
* Not pregnant (female participant of childbearing potential must have a negative urine pregnancy test before surgery).
* Not lactating.
* Not planning to become pregnant during the study.
* Be surgically sterile; or at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by Health Canada for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study.
7. In the opinion of the Investigator, is willing and able to understand the study procedures, and agrees to adhere to the requirements of the study protocol, in order to enable accurate and appropriate responses to pain scales.
Exclusion Criteria
2. History of hypersensitivity to any ingredient in the formulation (hyaluronan or methylcellulose).
3. History of hypersensitivity or allergy to amide type local anaesthetics (lidocaine, bupivacaine, or ropivacaine).
4. History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker.
5. Have a clinically significant abnormal clinical laboratory test value, according to the judgement of the investigator.
6. Have a clinically significant 12-lead ECG abnormality, according to the judgement of the investigator.
7. Have received any 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; sedative; strong inhibitors of cytochrome P4501A2 such as fluvoxamine enoxacin, theophylline and imipramine for at least 5 half-lives prior to the start of this).
8. Have received any investigational product within 30 days before dosing with study medication.
9. Suspected or known history of substance abuse and/or alcoholism.
18 Years
ALL
No
Sponsors
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AmacaThera Inc.
INDUSTRY
Responsible Party
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Countries
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Other Identifiers
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AMT-143-002
Identifier Type: -
Identifier Source: org_study_id