Postsurgical Analgesia After Hernia Repair

AmacaThera Inc.

Status and phase: Withdrawn; Phase 2

Conditions: Hernia Inguinal; Hernia, Inguinal; Hernia Repair; Hernia, Inguinal/Surgery; Hernia Surgery

Treatments: Drug: ropivacaine; Drug: AMT-143; Other: Saline (NaCl 0,9 %) (placebo)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06709612

AMT-143-002

Details and patient eligibility

About

The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of three ascending doses of AMT-143 to determine the appropriate dose of AMT-143 for the management of postsurgical pain following inguinal hernia repair.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The following inclusion criteria apply to all participants scheduled for open inguinal hernia repair in all cohorts.

1. Provides voluntary written informed consent.

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

The following exclusion criteria apply to all participants in all cohorts.

1. Have chronic pain and have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of study treatment initiation.
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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups, including a placebo group

AMT-143

Experimental group

Treatment:

Drug: AMT-143

Saline Placebo

Placebo Comparator group

Treatment:

Other: Saline (NaCl 0,9 %) (placebo)

Ropivacaine solution

Active Comparator group

Treatment:

Drug: ropivacaine