drugset / Trial / NCT03262688

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

NCT03262688

Phase 3 Unknown 159 enrolled Innocoll Premier Research · collab
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2017-06-16
Primary completion
2024-01-31
Completion
2024-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 2.5 mg/kg Other

Indications

No indication recorded.