AMT-143 Hydrogel for Pain After Hernia Surgery

Overseen By Chief Executive Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AmacaThera Inc.

Must not be taking: Opioids, Antiarrhythmics, Sedatives, others

Disqualifiers: Chronic pain, Hypersensitivity, Heart issues, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AMT-143, a hydrogel with a pain-relieving ingredient, to evaluate its effectiveness in managing pain after hernia surgery. Researchers aim to determine the optimal dose of AMT-143 for safe and effective pain reduction. They compare AMT-143 to a standard pain solution and a placebo (a substance with no active treatment) to ensure its superior efficacy. Candidates for this study include individuals scheduled for inguinal hernia surgery who do not have chronic pain. Participants will receive the treatment during surgery and attend follow-ups to assess pain levels and recovery. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking medications that might interact with ropivacaine, such as certain local anesthetics or antiarrhythmics, and you must not have taken any investigational products within 30 days before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AMT-143, a gel used during surgery, aims to provide long-lasting pain relief without opioids, helping to avoid certain risks. Early studies found that patients tolerated this treatment well, with no serious side effects reported, suggesting it might be safe. However, as this trial remains in the early stages, further research is needed to confirm these results. Prospective participants should know that AMT-143 is still being tested to determine the best and safest dose for reducing post-surgical pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the typical pain management options after hernia surgery, which often rely on oral medications or injections, AMT-143 introduces a novel delivery method using a hydrogel. This hydrogel allows for the sustained release of ropivacaine, a well-known anesthetic, directly at the surgical site. Researchers are excited because this targeted approach could provide longer-lasting pain relief with potentially fewer side effects than traditional systemic treatments. Additionally, by adjusting the hydrogel volume, the release and dosage can be tailored to the patient's specific needs, offering a personalized pain management solution.

What evidence suggests that AMT-143 hydrogel could be effective for managing postsurgical pain after hernia surgery?

This trial will compare AMT-143 hydrogel with a Ropivacaine solution and a placebo for pain management after hernia surgery. Research has shown that AMT-143 hydrogel is designed to provide long-lasting pain relief directly at the surgery site. Earlier studies suggest it might reduce the need for opioid medications, which are strong and potentially addictive painkillers. In initial studies, patients who used AMT-143 reported less pain after surgery compared to those who did not use it. The hydrogel slowly releases ropivacaine, a common local pain reliever, to manage pain effectively. This treatment could offer a safer option for handling post-surgery pain. ^{1 3 4 6 7}

Who Is on the Research Team?

James Paul, MD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 who are scheduled for open inguinal hernia repair surgery. They must be able to receive general anesthesia and agree to post-surgery follow-up. People with conditions that might interfere with the study or pose a risk if they participate are not eligible.

Inclusion Criteria

Body mass index (BMI) ≤40.0 kg/m2

Provides voluntary written informed consent

I am scheduled for open surgery to repair a hernia in my groin.

Exclusion Criteria

History of hypersensitivity or allergy to amide type local anaesthetics (lidocaine, bupivacaine, or ropivacaine)

Have a clinically significant abnormal clinical laboratory test value, according to the judgement of the investigator

Have a clinically significant 12-lead ECG abnormality, according to the judgement of the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AMT-143 or placebo or active control during surgery for postsurgical analgesia

1 day

1 visit (in-person)

Post-discharge Follow-up

Participants are monitored for safety, efficacy, and PK assessments on an outpatient basis

21 days

Home visits by nurse

End of Study Follow-up

Final assessments conducted at the clinical site to evaluate safety and efficacy

7 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AMT-143

Trial Overview The trial is testing three doses of AMT-143, a hydrogel containing ropivacaine, against a placebo and regular ropivacaine solution for pain management after hernia surgery. It's randomized and single-blind, meaning participants won't know which treatment they get.

How Is the Trial Designed?

Group I: active AMT-143 hydrogel Experimental Treatment 1 Intervention

6 participants in the first cohort will receive 1 mL AMT-143 hydrogel containing 385 mg ropivacaine. 6 participants in the second cohort will receive 2 mL AMT-143 hydrogel containing 770 mg ropivacaine. 6 participants in the third cohort will receive 3 mL AMT-143 hydrogel containing 1,155 mg ropivacaine

Group II: Ropivacaine solution Active Control 1 Intervention

2 participants in the first cohort will receive 5 mL Ropivacaine 10 mg 1% solution. 2 participants in the second cohort will receive 5 mL Ropivacaine 10 mg 1% solution. 2 participants in the third cohort will receive 5 mL Ropivacaine 10 mg 1% solution.

Group III: Placebo Placebo Group 1 Intervention

2 participants in the first cohort will receive 1 mL saline placebo. 2 participants in the second cohort will receive 1 mL saline placebo. 2 participants in the third cohort will receive 1 mL saline placebo.

Who Is Running the Clinical Trial?

AmacaThera Inc.

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study involving 72 pediatric patients with acute thermal burns, there was no significant difference in pain relief between Burnaid hydrogel dressing and plasticised polyvinylchloride film, indicating that neither dressing provided a clear analgesic advantage.

The trial, conducted over one year, showed that both dressings resulted in similar pain scores, stress levels, and re-epithelialisation rates, suggesting that Burnaid hydrogel dressing may not be a more effective option for pain management in pediatric burn treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial. Holbert, MD., Kimble, RM., Chatfield, M., et al.[2021]

Citations

1. amacathera.com amacathera.com/amacathera-doses-first-in-human-study-to-evaluate-amt-143-for-non-opioid-treatment-of-post-operative-pain

AmacaThera doses First In Human Study to Evaluate, AMT- ... If approved, AMT-143 could one day be used to reduce post-operative pain without the need for opioids. AMT-143 would be applied in the ...

2. mentalhealth.networkofcare.org mentalhealth.networkofcare.org/Lake/CommunityResources/ClinicalTrials/Detail/NCT06709612?keyword=%22Hernia%22

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- ...

3. biospace.com biospace.com/press-releases/amacathera-announces-phase-1-results-of-first-in-human-study-with-amt-143-exceeding-expectations-and-paving-the-way-for-a-novel-approach-to-post-operative-pain-relief

AmacaThera Announces Phase 1 Results of First-in- ... AMT-143 is intended to deliver extended, localized pain relief without the need for opioids, significantly reducing the risks associated with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12561313/

Hydrogel-Based Formulations to Deliver Analgesic Drugs This scoping review aimed to systematically map clinical applications, efficacy, and safety of hydrogel-based DDS for analgesics, while also documenting non-DDS ...

5. prnewswire.com prnewswire.com/news-releases/amacathera-announces-phase-1-results-of-first-in-human-study-with-amt-143-exceeding-expectations-and-paving-the-way-for-a-novel-approach-to-post-operative-pain-relief-302310726.html

AmacaThera Announces Phase 1 Results of First-in- ... AMT-143 is intended to deliver extended, localized pain relief without the need for opioids, significantly reducing the risks associated with ...

6. mdpi.com mdpi.com/2227-9059/13/10/2465

Hydrogel-Based Formulations to Deliver Analgesic Drugs This scoping review aimed to systematically map clinical applications, efficacy, and safety of hydrogel-based DDS for analgesics, while also documenting non-DDS ...

7. prnewswire.com prnewswire.com/news-releases/amacathera-doses-first-in-human-study-to-evaluate-amt-143-for-non-opioid-treatment-of-post-operative-pain-302145634.html

AmacaThera doses First In Human Study to Evaluate, AMT- ... AMT-143 would be applied in the incisional site at the time of surgery to control local pain. "A successful outcome will be data demonstrating ...