← Back to Search

AMT-143 Hydrogel for Pain After Hernia Surgery

Phase 2

Waitlist Available

Led By James Paul, MD

Research Sponsored by AmacaThera Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants are ≥18 years of age at screening

Scheduled to undergo unilateral open inguinal hernia repair

Must not have

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 ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from surgery to day 28 follow-up

Summary

"This trial is testing a new medication called AMT-143 to see how safe and effective it is in managing pain after inguinal hernia repair surgery. The study will involve 30 participants who

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include reactions at the injection site, nerve damage symptoms like numbness or weakness, allergic reactions to ropivacaine, nausea, vomiting, fever, dizziness or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

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

Select...

I am a male either sterile or using reliable birth control during and 1 week post-study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have chronic pain and have been on opioids stronger than 15 morphine units daily for most of the week in the past year.

Select...

I have had heart rhythm problems without a pacemaker.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from surgery to day 28 follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from surgery to day 28 follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and from surgery to day 28 follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events to determine Safety and tolerability of AMT-143

Pharmacokinetics of AMT-143

Secondary study objectives

Analgesic efficacy of AMT-143

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: active AMT-143 hydrogelExperimental Treatment1 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 solutionActive Control1 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: PlaceboPlacebo Group1 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.

0 / 5Eligibility criteria met