Hernia RepairPhase 2NCT06709612
Postsurgical Analgesia After Hernia Repair
A Phase 2 study testing AMT-143 and ropivacaine in people with Hernia Repair and Hernia Inguinal, run by AmacaThera Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia Repair, Hernia Inguinal, Hernia Surgery
- What is being tested?
- AMT-143 and ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2025to May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following inclusion criteria apply to all participants scheduled for open inguinal hernia repair in all cohorts.
- Provides voluntary written informed consent.
- Participants are ≥18 years of age at screening.
- Scheduled to undergo unilateral open inguinal hernia repair.
- Body mass index (BMI) ≤40.0 kg/m2.
- 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.
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- 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.
- 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.
Who cannot join
- The following exclusion criteria apply to all participants in all cohorts.
- 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.
- History of hypersensitivity to any ingredient in the formulation (hyaluronan or methylcellulose).
- History of hypersensitivity or allergy to amide type local anaesthetics (lidocaine, bupivacaine, or ropivacaine).
- History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker.
- Have a clinically significant abnormal clinical laboratory test value, according to the judgement of the investigator.
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- Have a clinically significant 12-lead ECG abnormality, according to the judgement of the investigator.
- 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).
- Have received any investigational product within 30 days before dosing with study medication.
- Suspected or known history of substance abuse and/or alcoholism.
About this study
Official title: Pilot Phase II Study of AMT-143 for Postsurgical Analgesia After Hernia Repair
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.
- Conditions
- Hernia Repair, Hernia Inguinal, Hernia Surgery, Hernia, Inguinal/Surgery, Hernia, Inguinal
- Being tested
- AMT-143, Saline (NaCl 0,9 %) (placebo), ropivacaine
- Medical subject headings
- Hernia, Inguinal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMT-143Drug
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)Other
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.
ropivacaineDrug
The active comparator, ropivacaine hydrochloride 1% solution will be administered at a volume of 5 mL (50 mg) for all 3 cohorts.
| Study group | Role | What they receive |
|---|---|---|
| AMT-143 | Experimental | Not described Receives: Drug: AMT-143 |
| Saline Placebo | Placebo comparator | Not described Receives: Other: Saline (NaCl 0,9 %) (placebo) |
| Ropivacaine solution | Active comparator | Not described Receives: Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events to evaluate the safety and tolerability of AMT-143
To evaluate the safety and tolerability of AMT-143 for postsurgical pain management following inguinal hernia repair surgery.
The safety endpoint of the study will be the incidence of Treatment Emergent Adverse Events (TEAEs). This will include reported Adverse Events as well as all clinically significant abnormalities in clinical laboratory investigations, vital signs, physical examination results, and ECG tracings.
Measured: From surgery to Day 28 follow-up
Pharmacokinetics of AMT-143
To assess the PK profile of AMT-143. Plasma samples will be analyzed for ropivacaine concentrations using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Incurred sample reanalysis will be performed on approximately 10% of study samples with a minimum of 20 samples for confirmation of results. At least two thirds of the incurred samples analyzed should have a percent difference between re-assay \& original concentrations within ±20%. Plasma concentration-time data for AMT-143 will be analyzed by the noncompartmental method to obtain the PK parameters using validated Phoenix WinNonlin® version 8.3 or higher software (Pharsight Corp).
Measured: From surgery to Day 28 follow-up
Secondary outcomes (1)
Analgesic efficacy of AMT-143
To evaluate analgesic efficacy of AMT-143 for postsurgical pain management following inguinal hernia repair surgery utilizing the Numeric Rating Scale (NRS).
The NRS runs from 0 (no pain) to 10 (worst pain).
Measured: From surgery to Day 28 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start27 Jan 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AmacaThera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709612
- Sponsor's protocol ID
- AMT-143-002
- Status last verified
- Dec 2025
- First submitted
- 31 Oct 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot study with limited enrollment.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Phase II Study of AMT-143 for Postsurgical Analgesia After Hernia Repair
- ClinicalTrials.gov ID
- NCT06709612
- Acronym / sponsor ID
- AMT-143-002
- Conditions
- Hernia Repair, Hernia Inguinal, Hernia Surgery, Hernia, Inguinal/Surgery, Hernia, Inguinal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmacaThera Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMT-143 | Experimental | Drug: AMT-143 |
| Saline Placebo | Placebo comparator | Other: Saline (NaCl 0,9 %) (placebo) |
| Ropivacaine solution | Active comparator | Drug: ropivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The following inclusion criteria apply to all participants scheduled for open inguinal hernia repair in all cohorts.
- Provides voluntary written informed consent.
- Participants are ≥18 years of age at screening.
- Scheduled to undergo unilateral open inguinal hernia repair.
- Body mass index (BMI) ≤40.0 kg/m2.
Key exclusion criteria (10 listed)
- The following exclusion criteria apply to all participants in all cohorts.
- 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.
- History of hypersensitivity to any ingredient in the formulation (hyaluronan or methylcellulose).
- History of hypersensitivity or allergy to amide type local anaesthetics (lidocaine, bupivacaine, or ropivacaine).
- History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMT-143AMT-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 | Drug | AMT-143 |
| 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. | Other | Saline Placebo |
| ropivacaineThe active comparator, ropivacaine hydrochloride 1% solution will be administered at a volume of 5 mL (50 mg) for all 3 cohorts. | Drug | Ropivacaine solution |
Primary outcome
Incidence of Treatment-Emergent Adverse Events to evaluate the safety and tolerability of AMT-143
Time frame: From surgery to Day 28 follow-up
To evaluate the safety and tolerability of AMT-143 for postsurgical pain management following inguinal hernia repair surgery. The safety endpoint of the study will be the incidence of Treatment Emergent Adverse Events (TEAEs). This will include reported Adverse Events as well as all clinically significant abnormalities in clinical laboratory investigations, vital signs, physical examination results, and ECG tracings.
Pharmacokinetics of AMT-143
Time frame: From surgery to Day 28 follow-up
To assess the PK profile of AMT-143. Plasma samples will be analyzed for ropivacaine concentrations using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Incurred sample reanalysis will be performed on approximately 10% of study samples with a minimum of 20 samples for confirmation of results. At least two thirds of the incurred samples analyzed should have a percent difference between re-assay \& original concentrations within ±20%. Plasma concentration-time data for AMT-143 will be analyzed by the noncompartmental method to obtain the PK parameters using validated Phoenix WinNonlin® version 8.3 or higher software (Pharsight Corp).
1 secondary outcome
Analgesic efficacy of AMT-143
Time frame: From surgery to Day 28 follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No. Pilot study with limited enrollment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMT-143 and ropivacaine in people with Hernia Repair and Hernia Inguinal, run by AmacaThera Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events to evaluate the safety and tolerability of AMT-143 (time frame: From surgery to Day 28 follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.