Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty

• Status: Completed
• Trial end date: 2017-08-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter randomized, single-blind, controlled study. The primary objectives of this study are to obtain the pharmacokinetic profile and the relative bioavailability of the INL-001 matrix during and after open hernioplasty compared to Marcaine™ 0.25% infiltration.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innocoll
• Collaborator: Medpace, Inc.
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

To be eligible for inclusion into the study, subjects must:

• Be a man or woman ≥18 years of age.

• Be eligible for unilateral inguinal hernioplasty with mesh (open laparotomy, tension-free technique) performed according to standard surgical technique under general anesthesia. Repair of multiple hernias through a single incision is permitted. If female of childbearing potential, have a negative pregnancy test at screening and before randomization on Day 1 AND be using an effective contraception method (ie, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study, OR be surgically sterile, OR be a postmenopausal female (no menses for at least 1 year or hysterectomy).

• Has the ability and willingness to comply with the study procedures.

• Be willing to use only permitted medications throughout the study.

• Be willing to use opioid analgesia.

• Be able to fluently speak and understand either English or Spanish and be able to provide meaningful written informed consent for the study.

Exclusion Criteria:

A subject will be excluded from study participation if prior to surgery he/she:

• Has a known hypersensitivity to amide local anesthetics, morphine, acetaminophen, or bovine products.

• Is scheduled for bilateral inguinal hernioplasty or other significant concomitant surgical procedure.

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

• Has known or suspected history of alcohol or drug abuse or misuse within 3 years of screening or evidence of tolerance or physical dependency on opioid analgesics or sedative-hypnotic medications.

• Has any clinically significant unstable cardiac, neurological, immunological, renal, hepatic or hematological disease or any other condition that, in the opinion of the investigator, could compromise the subject's welfare, ability to communicate with the study staff or otherwise contraindicate study participation.

• Has venous access difficulties that may preclude the frequent pharmacokinetic sampling requirements of the study.

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