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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innocoll
• Collaborators: Cmed; Premier Research Group plc
• Treatments: Analgesics; Bupivacaine; Epinephrine; Epinephryl borate; Racepinephrine

Criteria

Inclusion Criteria:

• Be a male or female 2 to <17 years of age.

• Be eligible for an elective open inguinal hernia repair that will be performed according to standard surgical technique under general anesthesia.

• Be premenarche or have a serum confirmed negative pregnancy test at screening and a negative urine pregnancy test before surgery on day 1, if an adolescent female of childbearing potential.

• Be willing and able to cooperate with all the requirements of the study.

• Be able to speak and understand English or Spanish.

• Have a legally authorized representative (eg, parent, guardian) who is able to read, speak, and understand English or Spanish and who will voluntarily sign and date a parental permission/informed consent form that is approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC).

• Be willing to sign an assent (if appropriate dependent upon the child's age, understanding, and IRB requirements), before the conduct of any study procedure.

Exclusion Criteria:

• Has a known hypersensitivity to amide local anesthetics, bovine products, or to inactive ingredients of the study drugs.

• Requires any additional surgical procedures, either related or unrelated to the scheduled surgery (ie, open inguinal hernia surgery), during the same hospitalization.

• Requires epidural or spinal blockade perioperatively.

• Is required to receive neuraxial (spinal or epidural) opioid analgesics during the study.

• Has undergone major surgery within 3 months of the scheduled surgery or plans to undergo another surgical procedure within the 30-day postoperative period.

• Has known or suspected history of drug abuse or misuse or evidence of tolerance or physical dependency on opioid analgesics or sedative-hypnotic medications.

• Has participated in a clinical trial (investigational or marketed product) within 30 days before surgery.

• Has any clinically significant medical history or condition (eg, unstable cardiac, neurological, immunological, renal, hepatic, or hematological disease or any other condition) that in the opinion of the investigator, substantially increases the risk associated with the subject's participation in the protocol or compromises the scientific objectives of the study.