Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02523599 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
A Phase 3 study, sponsored by Innocoll.
- Completed
- Registry status
- Phase 3
- Development phase
- 305
- Enrollment target
NCT02523599: Completed Phase 3 study, sponsored by Innocoll.
NCT02523599 is a Phase 3 study that has completed, run by Innocoll. The registered enrollment target is 305 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02523599, a Phase 3 study, has completed, sponsored by Innocoll.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 305 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Sum of Pain Intensity (SPI24). The time weighted sum of pain intensity from 0 to 24 hours (ie, the area under the NRS PI curve from 0 to 24 hours). Where 0 indicated "no pain" and 10 indicated "worst pain possible". This type of measurement scale is called "NRS" or Numerical Rating Scale For the purpose of (SPI) computation, PI at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation. SPI will not be calculated for randomized but not treated patients. A lower sc
Interventions
- OTHER Placebo
- DRUG XaraColl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 305 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-04 |
| Phase | Phase 3 |
What the finished NCT02523599 record still lists
NCT02523599 is an interventional study that assigns participants to a tested intervention. The registered 305 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02523599 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02523599 about?
NCT02523599 is a clinical study titled "Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty". 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 i...
What is the current status of trial NCT02523599?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 305 participants. The study started on 2015-08. Estimated completion is 2016-04.
What interventions are being tested in trial NCT02523599?
The interventions under investigation include: Placebo (OTHER), XaraColl (DRUG).
Who is sponsoring clinical trial NCT02523599?
This trial is sponsored by Innocoll, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02523599's enrollment target sits among peer trials
305 1117th of 2000 higher than 884 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04107181 · 305 participants · NA
Pilot Study for Speculum Free Cervical Cancer Screening
- NCT05399056 · 305 participants · NA
Improving Participation in Pulmonary Rehabilitation Through Peer Support and Storytelling
- NCT05078970 · 306 participants · NA
Advancing Suicide Intervention Strategies for Teens During High Risk Periods
- NCT05843695 · 306 participants · NA
Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia