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A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair

NCT00974350 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2021-05-27

Study results available
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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. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia.

The purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.

Conditions

  • Postoperative Pain
  • Hernia
  • Surgery

Interventions

DRUG

SABER-Bupivacaine

Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once

DRUG

SABER-Bupivacaine

Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once

DRUG

SABER-Placebo

Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once

Sponsors & Collaborators

  • Nycomed

    collaborator INDUSTRY

  • Durect

    lead INDUSTRY

Principal Investigators

  • Dmitri Lissin, MD · Durect

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00974350 on ClinicalTrials.gov