Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant

Hernioplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232178
• Other study ID #: INN-CB-013
• Status: Completed
• Phase: Phase 2
• Start date: October 20, 2014
• Est. completion date: March 23, 2015

Study information

• Verified date: September 2020
• Source: Innocoll
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 23, 2015
• Est. primary completion date: February 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernioplasty

Intervention

Drug:
• 2 100mg Xaracoll implants

• 3 100mg Xaracoll implants

• 150mg Bupivacaine HCl injection

Locations

Country	Name	City	State
United States	Pinnacle Research Group	Anniston	Alabama
United States	First Surgical Hospital	Bellaire	Texas
United States	Wexner Medical Center at Ohio State University	Columbus	Ohio
United States	Victory Hospital	Houston	Texas
United States	Shoals Medical Trials	Sheffield	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Innocoll	Premier Research Group plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.