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NCT01052012 · ClinicalTrials.gov registry record · Phase 3

Bupivacaine Effectiveness and Safety in SABER® Trial

A Phase 3 study of Postoperative Pain and Abdominal Surgery, sponsored by Durect.

Completed
Registry status
Phase 3
Development phase
331
Enrollment target
20
Study locations

NCT01052012 is a Phase 3 study of Postoperative Pain and Abdominal Surgery that has completed, run by Durect. The registered enrollment target is 331 participants, above the 226-participant average among 63 other Postoperative Pain trials with a reported enrollment target (46% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT01052012, a Phase 3 study of Postoperative Pain and Abdominal Surgery, has completed, sponsored by Durect.

COMPLETED
Registry status
Phase 3
Development phase
331 participants
Enrollment target
20
Study locations

Study Summary

This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. The purpose of this study is to investigate safety (side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.

Conditions Studied

Postoperative Pain Abdominal Surgery

Interventions

  • DRUG Bupivacaine HCl
  • DRUG SABER-Bupivacaine
  • DRUG SABER-Placebo

Study Locations (20)

Alabama

  • DURECT Study Site - Birmingham
  • DURECT Study Site - Florence
  • DURECT Study Site - Mobile
  • DURECT Study Site - Mobile
  • DURECT Study Site - Montgomery
  • DURECT Study Site - Sheffield

California

  • DURECT Study Site - Arcadia
  • DURECT Study Site - Fontana
  • DURECT Study Site - Laguna Hills
  • DURECT Study Site - Pasadena

Florida

  • DURECT Study Site - Tampa

Georgia

  • DURECT Study Site - Powder Springs

Indiana

  • DURECT Study Site - Indianapolis

Massachusetts

  • DURECT Study Site - Boston

Michigan

  • DURECT Study Site - Troy

Minnesota

  • DURECT Study Site - Duluth

Trial Details

FieldValue
Enrollment Target 331 participants
Start Date 2009-12
Est. Completion 2011-09
Phase Phase 3

Sponsor

Durect

10 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01052012

The ClinicalTrials.gov registry entry for NCT01052012 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 226-participant average among 63 other Postoperative Pain trials with a reported enrollment target (46% higher). The listed sponsor is Durect, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Postoperative Pain appearing as the primary indexed condition, and to 3 interventions - of which Bupivacaine HCl is the first listed.

NCT01052012 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Alabama, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01052012 about?

NCT01052012 is a clinical study titled "Bupivacaine Effectiveness and Safety in SABER® Trial". This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. The purpose of this study is to investigate safety...

What is the current status of trial NCT01052012?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2009-12. Estimated completion is 2011-09.

What conditions does trial NCT01052012 study?

This clinical trial studies the following conditions: Postoperative Pain, Abdominal Surgery.

What interventions are being tested in trial NCT01052012?

The interventions under investigation include: Bupivacaine HCl (DRUG), SABER-Bupivacaine (DRUG), SABER-Placebo (DRUG).

Who is sponsoring clinical trial NCT01052012?

This trial is sponsored by Durect, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01052012 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.