Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
Public ClinicalTrials.gov record NCT02523599. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the XaraColl® Bupivacaine Implant (300 mg Bupivacaine Hydrochloride) After Open Laparotomy Hernioplasty
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled efficacy and safety study of postoperative pain in adults who are scheduled for unilateral inguinal hernioplasty via open laparotomy (tension-free technique). Patients will assess their postoperative pain intensity (PI) using an 11-point numerical rating scale (NRS) from 0 hour through 72 hours postoperatively. The expected maximum study duration for each patient will be up to 60 days, including a maximum 30-day screening period, the day of surgery and implantation, and a 30-day post implantation period including treatment and follow-up.
Study identification
- NCT ID
- NCT02523599
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 305 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2015 (Type not available)
- Primary completion
- Apr 2016 (Actual)
- Completion
- Apr 2016 (Actual)
- Last update posted
- Jan 8, 2021
2015 – 2016
United States locations
- U.S. sites
- 23
- U.S. states
- 10
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Mobile | Alabama | 36617 | — |
| Not listed | Sheffield | Alabama | 35660 | — |
| Not listed | Phoenix | Arizona | 85023 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Encino | California | 91436 | — |
| Not listed | Bradenton | Florida | 34206 | — |
| Not listed | Clermont | Florida | 34711 | — |
| Not listed | Inverness | Florida | 34452 | — |
| Not listed | Kissimmee | Florida | 34741 | — |
| Not listed | Miami | Florida | 33136 | — |
| Not listed | Miami | Florida | 33144 | — |
| Not listed | Orlando | Florida | 32825 | — |
| Not listed | St. Petersburg | Florida | 33713 | — |
| Not listed | Tampa | Florida | 33606 | — |
| Not listed | Weston | Florida | 33331 | — |
| Not listed | Indianapolis | Indiana | 46202 | — |
| Not listed | Springfield | Massachusetts | 01199 | — |
| Not listed | Flint | Michigan | 48532 | — |
| Not listed | Las Vegas | Nevada | 89102 | — |
| Not listed | Las Vegas | Nevada | 89106 | — |
| Not listed | El Paso | Texas | 79935 | — |
| Not listed | Houston | Texas | 77054 | — |
| Not listed | Lampasas | Texas | 76550 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02523599, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 8, 2021 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02523599 live on ClinicalTrials.gov.