NCT02232178

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 20, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2015

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

August 23, 2018

Completed
Last Updated

October 20, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

September 3, 2014

Results QC Date

March 17, 2017

Last Update Submit

September 29, 2020

Conditions

Hernioplasty

Keywords

unilateral inguinal hernioplasty

Outcome Measures

Primary Outcomes (4)

  • 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.

Study Arms (3)

2 100mg Xaracoll implants

EXPERIMENTAL

Bupivacaine HCl implant

Drug: 2 100mg Xaracoll implants

3 100mg Xaracoll implants

EXPERIMENTAL

Bupivacaine HCl implant

Drug: 3 100mg Xaracoll implants

150mg Bupivacaine HCl injection

ACTIVE COMPARATOR

Bupivacaine HCl

Drug: 150mg Bupivacaine HCl injection

Interventions

2 100mg Xaracoll implantsDRUG
Also known as: Bupivacaine HCl implant
2 100mg Xaracoll implants
3 100mg Xaracoll implantsDRUG
Also known as: Bupivacaine HCl implant
3 100mg Xaracoll implants
150mg Bupivacaine HCl injectionDRUG
Also known as: Bupivacaine HCl
150mg Bupivacaine HCl injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Shoals Medical Trials

Sheffield, Alabama, 35660, United States

Location

Wexner Medical Center at Ohio State University

Columbus, Ohio, 43210, United States

Location

First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

Victory Hospital

Houston, Texas, 77704, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
Organization
Innocoll
ctucker@innocoll.com
484-406-5211

Study Officials

  • Gwendolyn Niebler, D.O.

    Innocoll

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 5, 2014

Study Start

October 20, 2014

Primary Completion

February 23, 2015

Study Completion

March 23, 2015

Last Updated

October 20, 2020

Results First Posted

August 23, 2018

Record last verified: 2020-09

Locations

US(5)