Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant

A Randomized, Blinded, Inpatient Study to Investigate the PK, Relative Bioavailability and Safety of 2 Doses of XaraColl (200 and 300 mg Bupivacaine HCl) Compared to Bupivacaine HCl Infiltration (150 mg) After Open Laparotomy Hernioplasty

Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.

Study Overview

• Status: Completed
• Conditions: Hernioplasty
• Intervention / Treatment: Drug: 2 100mg Xaracoll implants; Drug: 3 100mg Xaracoll implants; Drug: 150mg Bupivacaine HCl injection

Detailed Description

Inguinal hernioplasty is a common surgery. Common surgical methods used include laparoscopic and open placement of synthetic mesh. Managing postoperative pain and preventing morbidity after open mesh hernioplasty remain considerable medical challenges.

Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The Xaracoll implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the surgical site to provide postoperative pain control.

This study will assess the pharmacokinetic profile of 2 doses of the XaraColl implant after open laparotomy hernioplasty and assess the relative bioavailability of the Xaracoll implant compared to a local bupivacaine infiltration.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group
    • Sheffield, Alabama, United States, 35660
      • Shoals Medical Trials
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Wexner Medical Center at Ohio State University
  • Texas
    • Bellaire, Texas, United States, 77401
      • First Surgical Hospital
    • Houston, Texas, United States, 77704
      • Victory Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Man or woman who is ≥ 18 years of age
2. Has a planned unilateral inguinal hernioplasty (open laparotomy, tension free technique)
3. If female, is nonpregnant

Exclusion Criteria:

1. Scheduled for bilateral inguinal hernioplasty or other significant concomitant surgical procedures
2. Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to undergo another laparotomy procedure within 30 days postoperatively
3. 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 patient's welfare, ability to communicate with the study staff or otherwise contraindicate study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 100mg Xaracoll implants; Bupivacaine HCl implant	Drug: 2 100mg Xaracoll implants; Other Names: Bupivacaine HCl implant
Experimental: 3 100mg Xaracoll implants; Bupivacaine HCl implant	Drug: 3 100mg Xaracoll implants; Other Names: Bupivacaine HCl implant
Active Comparator: 150mg Bupivacaine HCl injection; Bupivacaine HCl	Drug: 150mg Bupivacaine HCl injection; Other Names: Bupivacaine HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum drug plasma concentration	0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
AUC0-last	Area under the plasma concentration-time curve from Time 0 to time of last quantifiable plasma concentration.	0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
Tmax	Time to maximum plasma concentration.	0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
t1/2 (Hour)	Terminal half-life.	0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.

Collaborators and Investigators

• Sponsor: Innocoll
• Collaborators: Premier Research Group plc
• Investigators: Study Director: Gwendolyn Niebler, D.O., Innocoll

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2014
• Primary Completion (Actual): February 23, 2015
• Study Completion (Actual): March 23, 2015

Study Registration Dates

• First Submitted: September 3, 2014
• First Submitted That Met QC Criteria: September 3, 2014
• First Posted (Estimate): September 5, 2014

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: unilateral inguinal hernioplasty
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: INN-CB-013