Overview

Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair

Status:
Recruiting
Trial end date:
2024-01-31
Target enrollment:
Participant gender:
Summary
A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, and 2 to <6 years of age who are scheduled for elective open inguinal hernia repair. Enrollment in this study will start with the oldest age group (12 to <17 years) and will continue in a stepwise fashion until appropriate doses are established for all 3 pediatric age groups (12 to <17 years, 6 to <12 years, 2 to <6 years).
Phase:
Phase 3
Details
Lead Sponsor:
Innocoll
Collaborators:
Cmed
Premier Research Group plc
Treatments:
Analgesics
Bupivacaine
Epinephrine
Epinephryl borate
Racepinephrine