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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 is a Phase 3 study that has completed, run by Durect. The registered enrollment target is 399 participants.

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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).

Interventions

  • DRUG Saline Placebo
  • DRUG Bupivacaine HCl
  • DRUG SABER-Bupivacaine (Part 1)
  • DRUG SABER-Bupivacaine (Part 2)

Trial Details

FieldValue
Enrollment Target 399 participants
Start Date 2015-11
Est. Completion 2017-08
Phase Phase 3

Sponsor

Durect

10 total trials

What the Registry Record Tells You About NCT02574520

The ClinicalTrials.gov registry entry for NCT02574520 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 399 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Durect, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Saline Placebo is the first listed.

NCT02574520 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.