Status:
COMPLETED
An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery
Lead Sponsor:
Durect
Collaborating Sponsors:
Nycomed
Hospira, now a wholly owned subsidiary of Pfizer
Conditions:
Pain
Eligibility:
All Genders
18+ years
Brief 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™...
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 trea...
Eligibility Criteria
Inclusion
- 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
- Participants who participated in any other trial with an investigational drug or device since their participation in DURECT protocol C803-017.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01139866
Start Date
June 1 2010
End Date
April 1 2011
Last Update
June 15 2022
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Westmead, New South Wales, Australia, 2145
2
Auchenflower, Queensland, Australia, 4066
3
Adelaide, South Australia, Australia, 5000
4
Toorak Gardens, South Australia, Australia, 5065