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Postsurgical Analgesia After Hernia Repair

NCT06709612 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-12-19

No results posted yet for this study

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.

Conditions

  • Hernia Repair
  • Hernia Inguinal
  • Hernia Surgery
  • Hernia, Inguinal/Surgery
  • Hernia, Inguinal

Interventions

DRUG

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

OTHER

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.

DRUG

ropivacaine

The active comparator, ropivacaine hydrochloride 1% solution will be administered at a volume of 5 mL (50 mg) for all 3 cohorts.

Sponsors & Collaborators

  • AmacaThera Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2026-03-31
Completion
2026-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06709612 on ClinicalTrials.gov