MedTrace Logo

A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery

NCT00818363 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-06-01

Study results available
· View outcomes & findings →

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 (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.

Conditions

  • Postoperative Pain

Interventions

DRUG

SABER-Bupivacaine

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

DRUG

SABER-Placebo

Injectable Solution; 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
2008-12-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

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 NCT00818363 on ClinicalTrials.gov