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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 is a Phase 3 study that has completed, run by Innocoll. The registered enrollment target is 319 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02525133
The ClinicalTrials.gov registry entry for NCT02525133 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 319 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Innocoll, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02525133 reports 0 study locations.
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.
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