Status:
COMPLETED
Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty
Lead Sponsor:
Innocoll
Collaborating Sponsors:
Medpace, Inc.
Conditions:
Hernioplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This is a multicenter randomized, single-blind, controlled study. Prior to surgery on Day 1, 48 subjects who continue to meet study entry criteria will be randomized just prior to surgery in a 2:1 rat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2017
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03234374
Start Date
June 2 2017
End Date
August 15 2017
Last Update
July 30 2021
Active Locations (5)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
2
Park Place Surgery Center
Longwood, Florida, United States, 32750
3
Research Concepts
Houston, Texas, United States, 77004
4
Research Concepts GP, LLC - Houston
Houston, Texas, United States, 77027