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

Durect47 enrolled

Overview

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).

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

Conditions

Pain

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Unnamed facility

Westmead, New South Wales, Australia

Unnamed facility

Auchenflower, Queensland, Australia

Unnamed facility

Adelaide, South Australia, Australia

Unnamed facility

Toorak Gardens, South Australia, Australia

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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