Trials / Completed
CompletedNCT01139866
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 47 (actual)
- Sponsor
- Durect · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
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 treatment will be given in this trial. Subjects, Investigators, and caregivers will remain blinded to the treatment subjects received in the previous trial.
Conditions
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2010-06-09
- Last updated
- 2022-06-15
Locations
8 sites across 2 countries: Australia, New Zealand
Source: ClinicalTrials.gov record NCT01139866. Inclusion in this directory is not an endorsement.