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

Status unconfirmed · Phase 3

Conditions studied: Inguinal Hernia, Postoperative Pain

In brief

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).

Key facts

Study ID

NCT03262688

Run by

Innocoll

People needed

159

Starts

2017-06-16

Expected to finish

2024-01-31

Last updated by the study team

2021-07-30

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alliance Research Centers — Laguna Hills, California, United States (enrolling)
• Cornerstone Research Institute — Altamonte Springs, Florida, United States (enrolling)
• Driscoll Children's Hospital — Corpus Christi, Texas, United States (enrolling)
• El Paso Children's Hospital — El Paso, Texas, United States (enrolling)
• Memorial Hermann Memorial City Medical Center — Houston, Texas, United States (enrolling)
• Plano Surgical Hospital — Plano, Texas, United States (enrolling)
• Children's Hospital of Pittsburgh of UPMC (CHP-UPMC) — Pittsburgh, Pennsylvania, United States (enrolling)
• Medical Research Center — Miami, Florida, United States
• Elion & Volhard Pharmaceutical Research (E&V PR) — Miami, Florida, United States
• The Woman's Hospital of Texas — Houston, Texas, United States
• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.