NCT06709612

Postsurgical Analgesia After Hernia Repair

Pilot Phase II Study of AMT-143 for Postsurgical Analgesia After Hernia Repair

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AmacaThera Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-01-27
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2024-11-29
• Last updated: 2025-12-19