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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01052012




Registration number
NCT01052012
Ethics application status
Date submitted
18/01/2010
Date registered
20/01/2010
Date last updated
22/12/2011

Titles & IDs
Public title
Bupivacaine Effectiveness and Safety in SABER™ Trial
Scientific title
Bupivacaine Effectiveness and Safety in SABER™ Trial (BESST)
Secondary ID [1] 0 0
C803-025
Universal Trial Number (UTN)
Trial acronym
BESST
Linked study record

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

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

Experimental: Active: SABER™-Bupivacaine - SABER™-Bupivacaine

Active Comparator: Comparator: Bupivacaine HCl - Bupivacaine HCl

Placebo Comparator: Placebo: SABER™-Placebo - SABER™-Placebo


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

Treatment: Drugs: Bupivacaine HCl
Injectable Solution; Bupivacaine HCl /Once

Treatment: Drugs: SABER™-Placebo
Injectable Solution; SABER™-Placebo/Once

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

Outcomes
Primary outcome [1] 0 0
Pain intensity on movement
Timepoint [1] 0 0
0 to 3 days post-dose
Primary outcome [2] 0 0
Supplemental opioid use
Timepoint [2] 0 0
0 to 3 days post-dose
Secondary outcome [1] 0 0
Mean pain intensity on movement
Timepoint [1] 0 0
0 to 2 days post-dose
Secondary outcome [2] 0 0
Mean total morphine-equivalent dose
Timepoint [2] 0 0
0 to 2 days post-dose
Secondary outcome [3] 0 0
Proportion of patients who have evidence of a wound infection
Timepoint [3] 0 0
0 to 14 days post-dose
Secondary outcome [4] 0 0
Time-to-first use of opioid rescue medication
Timepoint [4] 0 0
0 to 14 days post-dose
Secondary outcome [5] 0 0
Incidence of opioid-related side effects
Timepoint [5] 0 0
0 to 30 days post-dose
Secondary outcome [6] 0 0
Mean pain intensity at rest during
Timepoint [6] 0 0
0 to 3 days post-dose
Secondary outcome [7] 0 0
Mean pain intensity at rest
Timepoint [7] 0 0
0 to 2 days post-dose
Secondary outcome [8] 0 0
Mean scores on the Recovery Index
Timepoint [8] 0 0
0 to 7 days post-dose
Secondary outcome [9] 0 0
Modified Post-Anesthetic Discharge Scoring System
Timepoint [9] 0 0
0 to 14 days post-dose
Secondary outcome [10] 0 0
Treatment satisfaction
Timepoint [10] 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 years of age and older scheduled to undergo elective general
abdominal surgery

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

- BMI < 45

- Patients must have ECG wave form within normal limits

- Female and male patients must agree to use medically acceptable method of
contraception throughout the entire trial period and for 1 week after the trial
participation is completed
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who are pregnant or lactating

- Patients undergoing emergency surgery (unless full consent is obtained and all
screening procedures are completed prior to surgery)

- Significant concomitant surgical procedure

- History of multiple prior laparotomy procedures

- Cancer with known metastases pre-operatively, which are suspected to impact
post-operative recovery or pain

- Planned formation of stoma during surgery or plans to undergo another laparotomy
procedure within 30 days post-operatively

- Pre-operative evidence of sepsis or septic shock

- Pre-operative evaluation that suggests a surgery may preclude full closure of the
incision(s)

- Patients with current or regular use of systemic steroids, anticonvulsants,
antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be
withdrawn from these medications

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

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

- Patients with known hypersensitivity to morphine

- Patients with conditions contraindicated for use of opioids

- Patients with atrial fibrillation/flutter or other non-sinus rhythm (including paced
rhythm); left bundle branch block (LBBB); or the following conditions: right bundle
branch block (RBBB) in presence of a cardiac disease, significant cardiomyopathy, and
myocardial infarction within last 6 months

- Patients with a serum creatinine level two times more than the local laboratory normal
limit

- Patients who have received greater than 600 mg morphine equivalent daily dose for
three or more days per week in the month prior to the surgical procedure

- Patients who are currently being treated with methadone, or history of methadone use
within the previous 6 months

- 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 3
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)
SA,VIC
Recruitment hospital [1] 0 0
DURECT Study Site - Woodville South
Recruitment hospital [2] 0 0
DURECT Study Site - Box Hill
Recruitment hospital [3] 0 0
DURECT Study Site - Ringwood East
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3135 - Ringwood East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
New Zealand
State/province [14] 0 0
Christchurch

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 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 (side effects) associated with the use of
SABER™-Bupivacaine and how well it works in reducing pain and opioid-related side effects
following various kinds of abdominal surgeries.
Trial website
https://clinicaltrials.gov/show/NCT01052012
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