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COMPLETED Phase 3

Bupivacaine Effectiveness and Safety in SABER® Trial

NCT01052012 · View on ClinicalTrials.gov ↗

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.

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

1 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Durect, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01052012 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Alabama, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01052012?

The interventions under investigation include: Bupivacaine HCl (DRUG), SABER-Bupivacaine (DRUG), SABER-Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01052012?

This trial is sponsored by Durect, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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