Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01139866




Registration number
NCT01139866
Ethics application status
Date submitted
25/05/2010
Date registered
9/06/2010
Date last updated
15/06/2022

Titles & IDs
Public title
An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery
Scientific 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
Secondary ID [1] 0 0
C803-017e
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
18 months post-dose in C803-017 trial

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants who participated in any other trial with an investigational drug or
device since their participation in DURECT protocol C803-017.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2011
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Westmead
Recruitment hospital [2] 0 0
- Auchenflower
Recruitment hospital [3] 0 0
- Adelaide
Recruitment hospital [4] 0 0
- Toorak Gardens
Recruitment hospital [5] 0 0
- Geelong
Recruitment hospital [6] 0 0
- Ringwood East
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
3135 - Ringwood East
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Durect
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Nycomed
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Hospira, now a wholly owned subsidiary of Pfizer
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01139866
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dmitri Lissin, MD
Address 0 0
Durect
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01139866