An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery
A Multi-Center, Prospective, Observational, Extension Trial Following DURECT Protocol C803-017 to Investigate the Long-term Safety of SABER™-Bupivacaine Following Arthroscopic Shoulder Surgery
1 other identifier
observational
47
2 countries
8
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™-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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2010
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJune 15, 2022
June 1, 2022
10 months
May 25, 2010
June 13, 2022
Conditions
Keywords
Outcome Measures
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
18 months post-dose in C803-017 trial
Study Arms (2)
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
Eligibility Criteria
All available subjects who received treatment in DURECT protocol C803-017.
You may qualify if:
- 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.
You may not qualify if:
- Participants who participated in any other trial with an investigational drug or device since their participation in DURECT protocol C803-017.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Durectlead
- Nycomedcollaborator
- Hospira, now a wholly owned subsidiary of Pfizercollaborator
Study Sites (8)
Unknown Facility
Westmead, New South Wales, 2145, Australia
Unknown Facility
Auchenflower, Queensland, 4066, Australia
Unknown Facility
Adelaide, South Australia, 5000, Australia
Unknown Facility
Toorak Gardens, South Australia, 5065, Australia
Unknown Facility
Geelong, Victoria, 3220, Australia
Unknown Facility
Ringwood East, Victoria, 3135, Australia
Unknown Facility
Christchurch, 8014, New Zealand
Unknown Facility
Hamilton, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dmitri Lissin, MD
Durect
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2010
First Posted
June 9, 2010
Study Start
June 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
June 15, 2022
Record last verified: 2022-06