An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery
Launched by DURECT · Jun 8, 2010
Trial Information
Current as of June 09, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
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.
About Durect
Durect is a biopharmaceutical company focused on developing innovative therapeutics that improve patient outcomes through its proprietary drug delivery technologies. With a commitment to addressing unmet medical needs, Durect specializes in formulating and advancing novel therapies for chronic conditions, leveraging its expertise in sustained-release formulations and targeted drug delivery systems. The company is dedicated to rigorous clinical research and collaboration with healthcare professionals to bring transformative solutions to the market, aiming to enhance the quality of life for patients across various therapeutic areas.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Adelaide, , Australia
Christchurch, , New Zealand
Hamilton, , New Zealand
Westmead, , Australia
Geelong, Victoria, Australia
Auchenflower, Queensland, Australia
Ringwood East, Victoria, Australia
Toorak Gardens, South Australia, Australia
Patients applied
Trial Officials
Dmitri Lissin, MD
Study Director
Durect
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials