MedTrace Logo

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

NCT03262688 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2021-07-30

No results posted yet for this study

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).

Conditions

  • Inguinal Hernia
  • Postoperative Pain

Interventions

DRUG

Bupivacaine HCl collagen-matrix implant

Placement of the bupivacaine collagen-matrix in the surgical site

DRUG

Bupivacaine HCl infiltration

Infiltration of the surgical site

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Innocoll

    lead INDUSTRY

Principal Investigators

  • Gwendolyn Niebler, DO · Innocoll

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2024-01-31
Completion
2024-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03262688 on ClinicalTrials.gov