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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.