NCT03262688

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

A Multicenter, Randomized, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Analgesic Effect of the INL-001 Bupivacaine Hydrochloride (HCl) Collagen-Matrix Implant in Children 2 to <17 Years of Age Following Open Inguinal Hernia Repair

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: Innocoll · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is 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. Within 21 days of surgery, eligible subjects will be screened and have routine clinical laboratory testing and an electrocardiogram performed. Subjects will then undergo an open inguinal hernia repair under general anesthesia according to the investigator's standard surgical practice on day 1. 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. Within each age group, the study will be conducted in 3 parts. Children in each age group who are randomized to INL-001 will receive approximately less than or equal to 2.5 mg/kg of INL-001. Study drug will be administered prior to wound closure. The INL-001 implant will be cut before placement into the surgical site using sterile technique. Children randomized to 0.25% bupivacaine HCl injection will receive 2.5 mg/kg according to standard practice. After completion of the surgical procedure, all subjects will remain in the post-anesthesia care unit for at least 3 hours and will be continuously monitored for safety. At the discretion of the investigator, subjects may receive rescue medication (opioid or nonopioid) upon request for the management of breakthrough pain and may receive an antiemetic for the management of nausea or vomiting. After the initial 3-hour period, subjects who are deemed stable may be discharged to the hospital ward. Subjects will remain housed in the hospital ward for at least 48 hours. Blood samples will be collected for pharmacokinetic analysis from a subset of 8 children in each age group after INL-001 is implanted.

Conditions

• Inguinal Hernia
• Postoperative Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-16
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2017-08-25
• Last updated: 2021-07-30

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study