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OpenTrials
Completed

NCT Number: NCT02232178

Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant

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.

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Key information

Conditions

Hernioplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pinnacle Research Group, Anniston, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Scheduled for bilateral inguinal hernioplasty or other significant concomitant surgical procedures
  • Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to undergo another laparotomy procedure within 30 days postoperatively
  • 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

Treatment and study plan

2 100mg Xaracoll implants

Drug

Other names: Bupivacaine HCl implant

3 100mg Xaracoll implants

Drug

Other names: Bupivacaine HCl implant

150mg Bupivacaine HCl injection

Drug

Other names: Bupivacaine HCl

Primary outcomes

  1. Cmax

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.

    Maximum drug plasma concentration

  2. AUC0-last

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.

    Area under the plasma concentration-time curve from Time 0 to time of last quantifiable plasma concentration.

  3. Tmax

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.

    Time to maximum plasma concentration.

  4. t1/2 (Hour)

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.

    Terminal half-life.

Sponsors and collaborators

Lead sponsor

Innocoll

Industry

Collaborators

  • Premier Research

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 5, 2014
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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