COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00818363




Registration number
NCT00818363
Ethics application status
Date submitted
5/01/2009
Date registered
7/01/2009
Date last updated
1/06/2021

Titles & IDs
Public title
A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery
Scientific title
A Double-Blind, Multi-Center, Placebo-Controlled Trial of SABER-Bupivacaine for Post-Operative Pain Control and Opioid Sparing/Opioid-Related Adverse Event Reduction Following Arthroscopic Shoulder Surgery
Secondary ID [1] 0 0
C803-017
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SABER-Bupivacaine
Treatment: Drugs - SABER-Placebo

Experimental: Group 1: SABER-Bupivacaine - 5.0 mL SABER-Bupivacaine/Once

Placebo Comparator: Group 2: SABER-Placebo - 5.0 mL SABER-Placebo/Once


Treatment: Drugs: SABER-Bupivacaine
Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once

Treatment: Drugs: SABER-Placebo
Injectable Solution; 5.0 mL SABER-Placebo/Once

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose. - Mean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.
Timepoint [1] 0 0
0 to 72 hours post-dose
Primary outcome [2] 0 0
Supplemental Opioid Use - Mean total morphine-equivalent dose during the period 0 to 72 hours post-dose
Timepoint [2] 0 0
0 to 72 hours post-dose
Secondary outcome [1] 0 0
Number (Frequency) of Participants Reporting Opioid-related Adverse Events - Frequency of subject-reported opioid-related AEs during 0 to 72 hours (0 to 3 days) post-dose and during the trial: constipation, drowsiness, dizziness, nausea, vomiting, respiratory depression, and urinary retention.
Timepoint [1] 0 0
0 to 72 hours post-dose
Secondary outcome [2] 0 0
Mean Pain Intensity on Movement AUC (Time-normalized AUC) During the Period 0 to 48 Hours Post-dose (0 to 2 Days Post-dose). - Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose (0 to 2 days post-dose). Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.
Timepoint [2] 0 0
0 to 48 hours post-dose
Secondary outcome [3] 0 0
Supplemental Opioid Use - Mean total morphine-equivalent dose during the period 0 to 48 hours post-dose (0 to 2 days post-dose)
Timepoint [3] 0 0
0 to 48 hours post-dose
Secondary outcome [4] 0 0
Time-to-first Use of Opioid Supplemental Pain Medication
Timepoint [4] 0 0
0 to 14 days post-dose
Secondary outcome [5] 0 0
Severity of Opioid-related Side Effects
Timepoint [5] 0 0
0 to 14 days post-dose

Eligibility
Key inclusion criteria
- Patients must be able to read and understand the consent form, provide written
consent, complete trial-related procedures, and communicate with the trial staff.

- Males and females, 18 to 65 years of age, scheduled for shoulder surgery.

- Patients must be healthy or have only mild systemic disease.

- Patients must have ECG wave form within normal limits

- Patients must have blood pressure within normal range.

- Male and female patients must agree to use medically acceptable method of
contraception throughout the entire trial period and for 1 week after the trial is
completed.

- Patients must refrain from strenuous activities and avoid changes to prescribed
exercise levels throughout the course of the trial.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with previous arthroscopic surgery or open surgery on the study shoulder.

- Patients with chronic pain conditions requiring continuous use of corticosteroids for
greater than 3 months.

- Patients with fibromyalgia, rheumatoid arthritis, and/or sero-negative inflammatory
arthropathies.

- Patients with a below normal calculated creatinine clearance.

- Patients who are pregnant or lactating.

- Patients currently receiving more than 20 mg of hydrocodone daily (or equivalent
narcotic dose) on routine basis.

- Patients, who in the Investigator's opinion, have developed opioid tolerance.

- Patients with current or regular use of anticonvulsants, antiepileptics,
antidepressants, or monoamine oxidase inhibitors at screening.

- Patients with current or regular use of drugs known to significantly prolong the
corrected QT interval

- Patients with known hypersensitivity to local anesthetic agents of the amide type
(e.g., lidocaine, bupivacaine).

- Patients with known hypersensitivity to opioids.

- Patients with conditions contraindicated for use of opioids.

- Patients with known or suspected abuse of opioids or other illicit drugs.

- Patients with known or suspected alcohol abuse.

- Participation in another clinical trial at the same time or within 30 days of this
trial.

- Patients who, in the Investigator's opinion, should not participate in the trial or
may not be capable of following the trial schedule for any reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
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
- Kippa Ring
Recruitment hospital [3] 0 0
- Adelaide
Recruitment hospital [4] 0 0
- Toorak Gardens
Recruitment hospital [5] 0 0
- Geelong
Recruitment hospital [6] 0 0
- Hampton
Recruitment hospital [7] 0 0
- Ringwood East
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4021 - Kippa Ring
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
3188 - Hampton
Recruitment postcode(s) [7] 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

Ethics approval
Ethics application status

Summary
Brief summary
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving
medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common
local anesthetic, for a few days in order to treat local post-surgical pain.

The purpose of this study is to investigate safety (if there are any side effects) associated
with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related
side effects following shoulder surgery.
Trial website
https://clinicaltrials.gov/show/NCT00818363
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
Other publications