An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery
This study has been completed.
Sponsor:
Durect
Collaborators:
Nycomed: A Takeda Company
Hospira, Inc.
Information provided by:
Durect
ClinicalTrials.gov Identifier:
NCT01139866
First received: May 25, 2010
Last updated: July 13, 2011
Last verified: July 2011
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Purpose
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).
| Condition |
|---|
|
Pain |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Durect:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 47 |
| Study Start Date: | June 2010 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All available subjects who received treatment in DURECT protocol C803-017.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139866
Locations
| Australia, New South Wales | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Auchenflower, Queensland, Australia, 4066 | |
| Australia, South Australia | |
| Adelaide, South Australia, Australia, 5000 | |
| Toorak Gardens, South Australia, Australia, 5065 | |
| Australia, Victoria | |
| Geelong, Victoria, Australia, 3220 | |
| Ringwood East, Victoria, Australia, 3135 | |
| New Zealand | |
| Christchurch, New Zealand, 8014 | |
| Hamilton, New Zealand | |
Sponsors and Collaborators
Durect
Nycomed: A Takeda Company
Hospira, Inc.
Investigators
| Study Director: | Dmitri Lissin, MD | Durect Corporation |
More Information
No publications provided
| Responsible Party: | Christina Blevins, Clinical Research Associate, DURECT Corporation |
| ClinicalTrials.gov Identifier: | NCT01139866 History of Changes |
| Other Study ID Numbers: | C803-017e |
| Study First Received: | May 25, 2010 |
| Last Updated: | July 13, 2011 |
| Health Authority: | Australia: Human Research Ethics Committee New Zealand: Health Research Council |
Keywords provided by Durect:
|
Long-term Safety Shoulder Surgery bupivacaine |
Additional relevant MeSH terms:
|
Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013