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CompletedNCT01139866Updated Jun 15, 2022

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

An observational study in Pain, sponsored by Durect. Completed at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-15.

Sponsored by Durect · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
47
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Pain

Keywords

  • Long-term Safety
  • Shoulder Surgery
  • bupivacaine
03

In context

Lead sponsor

Durect is the lead sponsor of 15 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Participants who participated in any other trial with an investigational drug or device since their participation in DURECT protocol C803-017.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
47 participants (actual)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

8 sites
  • Westmead, New South Wales 2145, Australia
  • Auchenflower, Queensland 4066, Australia
  • Adelaide, South Australia 5000, Australia
  • Toorak Gardens, South Australia 5065, Australia
  • Geelong, Victoria 3220, Australia
  • Ringwood East, Victoria 3135, Australia
  • Christchurch, 8014, New Zealand
  • Hamilton, New Zealand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01139866
Lead sponsor
Durect
Collaborators
Nycomed, Hospira, now a wholly owned subsidiary of Pfizer
Responsible party
Sponsor
First posted
Jun 9, 2010
Start date
Jun 2010
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Jun 15, 2022

Study contacts

Dmitri Lissin, MD
study director · Durect

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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