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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/NCT00974350
Registration number
NCT00974350
Ethics application status
Date submitted
8/09/2009
Date registered
10/09/2009
Date last updated
27/05/2021
Titles & IDs
Public title
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
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Scientific title
A Double-Blind, Placebo-Controlled, Pharmacodynamic and Pharmacokinetic Dose Response Study of SABER-Bupivacaine Instilled Into the Wound in Patients Undergoing Open Inguinal Hernia Repair
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Secondary ID [1]
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CLIN803-006-0006
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postoperative Pain
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Hernia
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Surgery
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SABER-Bupivacaine
Treatment: Drugs - SABER-Bupivacaine
Treatment: Drugs - SABER-Placebo
Experimental: Group 1: SABER-Bupivacaine - 2.5 mL SABER-Bupivacaine/Once
Experimental: Group 2: SABER-Bupivacaine - 5.0 mL SABER-Bupivacaine/Once
Placebo Comparator: Group 3: SABER-Placebo - 2.5 mL or 5.0 mL SABER-Placebo/Once
Treatment: Drugs: SABER-Bupivacaine
Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once
Treatment: Drugs: SABER-Bupivacaine
Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
Treatment: Drugs: SABER-Placebo
Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pain Intensity on Movement
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Assessment method [1]
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Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
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Timepoint [1]
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1 to 72 hours post-dose
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Primary outcome [2]
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Proportion (Percent) of Patients Using Supplemental Opioids
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Assessment method [2]
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Timepoint [2]
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0 to 14 days post-dose
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Secondary outcome [1]
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Pain Intensity
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Assessment method [1]
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Pain intensity AUC over the time period of 1 to 48 hours. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
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Timepoint [1]
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1 to 48 hours post-dose
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Secondary outcome [2]
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Treatment Satisfaction
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Assessment method [2]
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Modified Brief Pain Inventory -An overall assessment of treatment satisfaction was made using 6 point verbal rating scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied).
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Timepoint [2]
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1 to 5 days post-dose
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Secondary outcome [3]
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Supplemental Opioid Use
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Assessment method [3]
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Timepoint [3]
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0 to 14 days post-dose
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Secondary outcome [4]
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Mean Function Activities (Modified Brief Pain Inventory)
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Assessment method [4]
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In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)
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Timepoint [4]
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1 to 5 days post-dose
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Eligibility
Key inclusion criteria
- Males and females, 18 to 65 years of age, scheduled for hernia repair surgery
- Patients must be in good health prior to study participation
- Patients must have blood pressure within normal range or with Stage 1 high blood
pressure
- 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
- Ability to read, understand, communicate, and voluntarily sign the informed consent
form prior to any trial specific procedures
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients with previous abdominal surgery scar tissue
- Patients with clinically significant abnormalities of any body system unrelated to the
disease under study
- Connective tissue disorders
- Patients who are pregnant or lactating
- Current or regular use of analgesic medication for other indications
- Patients with current or regular use of antidepressants or monoamine oxidase
inhibitors at screening
- Use of any drugs or medication that may interfere with the study and its results
- Patients with known hypersensitivity to the study drugs or their components
- Patients with known or suspected alcohol abuse or illicit drug use
- Participation in another clinical trial at the same time or within 30 days of this
trial
- Patient is unwilling to comply with the study procedures
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2007
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Sample size
Target
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Accrual to date
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Final
124
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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- Cairns
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Recruitment hospital [2]
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- Sunnybank
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Recruitment hospital [3]
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- Port Lincoln
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Recruitment hospital [4]
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- Ringwood East
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Recruitment postcode(s) [1]
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4870 - Cairns
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Recruitment postcode(s) [2]
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4109 - Sunnybank
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Recruitment postcode(s) [3]
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5606 - Port Lincoln
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Recruitment postcode(s) [4]
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3135 - Ringwood East
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Hamilton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Durect
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Nycomed
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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. This study is
testing SABER-Bupivacaine in people having surgery to repair a hernia.
The purpose of the study is to measure and compare the safety (side effects), tolerability
(ability to tolerate), and efficacy (how well it works) of two different volumes of
SABER-Bupivacaine with SABER-Placebo.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00974350
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dmitri Lissin, MD
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Address
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Durect
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00974350
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