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NCT02525133 · 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
- 319
- Enrollment target
NCT02525133: Completed Phase 3 study, sponsored by Innocoll.
NCT02525133 is a Phase 3 study that has completed, run by Innocoll. The registered enrollment target is 319 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02525133, a Phase 3 study, has completed, sponsored by Innocoll.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 319 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
The primary efficacy variable (time-weighted sum of pain intensity from Time 0 through 24 hours \[SPI24\]) was compared once at a 2-sided 0.05 level. Therefore, no multiplicity adjustment was necessary for the primary efficacy analysis. Pain Intensity was assessed by the subject using the 11-point NRS, where 0 indicated "no pain" and 10 indicated "worst pain possible". Minimum value would be "0" and Maximum value would be 240. Time-weighted SPI is calculated as the sum of the pain intensities be
Interventions
- OTHER Placebo
- DRUG XaraColl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2015-09-05 |
| Est. Completion | 2016-04-22 |
| Phase | Phase 3 |
What the finished NCT02525133 record still lists
NCT02525133 is an interventional study that assigns participants to a tested intervention. The registered 319 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 (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02525133 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02525133 about?
NCT02525133 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 NCT02525133?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 319 participants. The study started on 2015-09-05. Estimated completion is 2016-04-22.
What interventions are being tested in trial NCT02525133?
The interventions under investigation include: Placebo (OTHER), XaraColl (DRUG).
Who is sponsoring clinical trial NCT02525133?
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 NCT02525133's enrollment target sits among peer trials
319 1087th of 2000 higher than 914 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
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