HernioplastyPhase 2NCT02232178
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
A Phase 2 study testing 2 100mg Xaracoll implants, 3 100mg Xaracoll implants and 150mg Bupivacaine HCl injection in people with Hernioplasty, run by Innocoll at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernioplasty
- What is being tested?
- 2 100mg Xaracoll implants, 3 100mg Xaracoll implants and 150mg Bupivacaine HCl injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Oct 2014to 23 Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman who is ≥ 18 years of age
- Has a planned unilateral inguinal hernioplasty (open laparotomy, tension free technique)
- If female, is nonpregnant
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pinnacle Research Group
Anniston, Alabama, 36207
First Surgical Hospital
Bellaire, Texas, 77401
Wexner Medical Center at Ohio State University
Columbus, Ohio, 43210
Victory Hospital
Houston, Texas, 77704
Shoals Medical Trials
Sheffield, Alabama, 35660
About this study
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
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.
Read the 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.
- Conditions
- Hernioplasty
- Being tested
- 2 100mg Xaracoll implants, 3 100mg Xaracoll implants, 150mg Bupivacaine HCl injection
- Keywords
- unilateral inguinal hernioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 100mg Xaracoll implantsDrug
Also called Bupivacaine HCl implant
3 100mg Xaracoll implantsDrug
Also called Bupivacaine HCl implant
150mg Bupivacaine HCl injectionDrug
Also called Bupivacaine HCl
| Study group | Role | What they receive |
|---|---|---|
| 2 100mg Xaracoll implants | Experimental | Bupivacaine HCl implant Receives: Drug: 2 100mg Xaracoll implants |
| 3 100mg Xaracoll implants | Experimental | Bupivacaine HCl implant Receives: Drug: 3 100mg Xaracoll implants |
| 150mg Bupivacaine HCl injection | Active comparator | Bupivacaine HCl Receives: Drug: 150mg Bupivacaine HCl injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum drug plasma concentration
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study start20 Oct 2014
- Primary completion23 Feb 2015
- Study completion23 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HernioplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innocoll
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Niebler, D.O., Study director, Innocoll
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232178
- Sponsor's protocol ID
- INN-CB-013
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2014
- Last updated
- 20 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02232178
- Acronym / sponsor ID
- INN-CB-013
- Conditions
- Hernioplasty
- Keywords
- unilateral inguinal hernioplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- InnocollIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 20 Oct 2014 (actual)
- Primary completion
- 23 Feb 2015 (actual)
- Study completion
- 23 Mar 2015 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Posted 23 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 100mg Xaracoll implants | Experimental | Drug: 2 100mg Xaracoll implantsBupivacaine HCl implant |
| 3 100mg Xaracoll implants | Experimental | Drug: 3 100mg Xaracoll implantsBupivacaine HCl implant |
| 150mg Bupivacaine HCl injection | Active comparator | Drug: 150mg Bupivacaine HCl injectionBupivacaine HCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Man or woman who is ≥ 18 years of age
- Has a planned unilateral inguinal hernioplasty (open laparotomy, tension free technique)
- If female, is nonpregnant
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 100mg Xaracoll implantsAlso: Bupivacaine HCl implant | Drug | 2 100mg Xaracoll implants |
| 3 100mg Xaracoll implantsAlso: Bupivacaine HCl implant | Drug | 3 100mg Xaracoll implants |
| 150mg Bupivacaine HCl injectionAlso: Bupivacaine HCl | Drug | 150mg Bupivacaine HCl injection |
Primary outcome
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
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwendolyn Niebler, D.O. study director
Innocoll
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2 100mg Xaracoll implants, 3 100mg Xaracoll implants and 150mg Bupivacaine HCl injection in people with Hernioplasty, run by Innocoll at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.