An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery

June 13, 2022 updated by: Durect

A Multi-Center, Prospective, Observational, Extension Trial Following DURECT Protocol C803-017 to Investigate the Long-term Safety of SABER™-Bupivacaine Following Arthroscopic Shoulder Surgery

This is an extension to a previous research trial testing SABER™-Bupivacaine (an experimental pain-relieving medication). The purpose of this extension trial is to assess whether treatment with SABER™-Bupivacaine or SABER™-Placebo has had any effect on healing of the participant's shoulder, wound, or the skin near their scar. This trial will also assess safety (side effects).

Study Overview

Status

Completed

Conditions

Detailed Description

This research trial will involve all available subjects who received treatment in DURECT Protocol C803-017. All subjects will have the same follow-up safety assessments performed. No experimental treatment will be given in this trial. Subjects, Investigators, and caregivers will remain blinded to the treatment subjects received in the previous trial.

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
    • South Australia
      • Adelaide, South Australia, Australia, 5000
      • Toorak Gardens, South Australia, Australia, 5065
    • Victoria
      • Geelong, Victoria, Australia, 3220
      • Ringwood East, Victoria, Australia, 3135
  • New Zealand
      • Christchurch, New Zealand, 8014
      • Hamilton, New Zealand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All available subjects who received treatment in DURECT protocol C803-017.

Description

Inclusion Criteria:

  • Participants must have provided written consent to participate in the trial prior to any trial procedures and understand that they are free to withdraw from the trial at any time.
  • Participants must be able to read and understand the consent form, complete trial-related procedures, and communicate with the trial staff.
  • Participants must have participated in DURECT Protocol C803-017 and received SABER™-Bupivacaine or SABER™-Placebo approximately 18 months before enrolling in this trial.

Exclusion Criteria:

  • Participants who participated in any other trial with an investigational drug or device since their participation in DURECT protocol C803-017.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1: SABER™-Bupivacaine
Received 5.0 mL SABER™-Bupivacaine in previous C803-017 trial
Group 2: SABER™-Placebo
Received 5.0 mL SABER™-Placebo in previous C803-017 trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety Summaries: Pain Intensity on Movement Evaluation; Surgical Site Healing and Local Tissue Evaluation; Shoulder Examination; MRI; Medical History Update; Adverse Events; and Concomitant Medications
Time Frame: 18 months post-dose in C803-017 trial
18 months post-dose in C803-017 trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Durect

Collaborators

Hospira, now a wholly owned subsidiary of Pfizer
Nycomed

Investigators

  • Study Director: Dmitri Lissin, MD, Durect

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C803-017e

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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