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

CompletedN/A

Sponsor: Durect

Conditions: Pain

Countries: Australia, New Zealand

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (8)

Westmead, New South Wales, Australia
Auchenflower, Queensland, Australia
Adelaide, South Australia, Australia
Toorak Gardens, South Australia, Australia
Geelong, Victoria, Australia
Ringwood East, Victoria, Australia
Christchurch, New Zealand
Hamilton, New Zealand