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NCT02574520 · ClinicalTrials.gov registry record · Phase 3
Trial of Extended Release Bupivacaine for Pain Relief After Surgery
A Phase 3 study, sponsored by Durect.
- Completed
- Registry status
- Phase 3
- Development phase
- 399
- Enrollment target
NCT02574520: Completed Phase 3 study, sponsored by Durect.
NCT02574520 is a Phase 3 study that has completed, run by Durect. The registered enrollment target is 399 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02574520, a Phase 3 study, has completed, sponsored by Durect.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 399 participants
- Enrollment target
Study Summary
This is a research study of SABER® -Bupivacaine, an experimental medication designed to reduce pain for up to 3 days after surgery. Given once by the surgeon at the end of surgery, SABER® - Bupivacaine delivers a locally-acting pain reliever directly to the surgical wound. The purpose of this study is to measure how well it works in reducing pain after laparoscopic cholecystectomy (surgery to remove the gall bladder) and to investigate the safety of SABER®-Bupivacaine (its side effects).
Primary Outcome
A derived measure computed based on a patient-reported numerical pain rating scale assessing pain as a whole number from 0 (no pain) to 10 (worst pain imaginable) when the subject sits up from a supine position. This measure was evaluated by electronic diary at 13 planned time points from 0 to 48 hours post-treatment. The values reported are mean pain scores for each treatment group.
Interventions
- DRUG Saline Placebo
- DRUG Bupivacaine HCl
- DRUG SABER-Bupivacaine (Part 1)
- DRUG SABER-Bupivacaine (Part 2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 399 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-08 |
| Phase | Phase 3 |
What the finished NCT02574520 record still lists
NCT02574520 is an interventional study that assigns participants to a tested intervention. The registered 399 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 (48% lower).
The record links to 0 conditions, and to 4 interventions - of which Saline Placebo is the first listed.
NCT02574520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02574520 about?
NCT02574520 is a clinical study titled "Trial of Extended Release Bupivacaine for Pain Relief After Surgery". This is a research study of SABER® -Bupivacaine, an experimental medication designed to reduce pain for up to 3 days after surgery. Given once by the surgeon at the end of surgery, SABER® - Bupivacaine delivers a locally-acting pain reliever directly to the surgical wound. The purpose of this study...
What is the current status of trial NCT02574520?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 399 participants. The study started on 2015-11. Estimated completion is 2017-08.
What interventions are being tested in trial NCT02574520?
The interventions under investigation include: Saline Placebo (DRUG), Bupivacaine HCl (DRUG), SABER-Bupivacaine (Part 1) (DRUG), SABER-Bupivacaine (Part 2) (DRUG).
Who is sponsoring clinical trial NCT02574520?
This trial is sponsored by Durect, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02574520's enrollment target sits among peer trials
399 962nd of 2000 higher than 1,038 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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