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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
CLIN803-006-0006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Pain 0 0
Hernia 0 0
Surgery 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain Intensity on Movement
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
1 to 72 hours post-dose
Primary outcome [2] 0 0
Proportion (Percent) of Patients Using Supplemental Opioids
Assessment method [2] 0 0
Timepoint [2] 0 0
0 to 14 days post-dose
Secondary outcome [1] 0 0
Pain Intensity
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
1 to 48 hours post-dose
Secondary outcome [2] 0 0
Treatment Satisfaction
Assessment method [2] 0 0
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).
Timepoint [2] 0 0
1 to 5 days post-dose
Secondary outcome [3] 0 0
Supplemental Opioid Use
Assessment method [3] 0 0
Timepoint [3] 0 0
0 to 14 days post-dose
Secondary outcome [4] 0 0
Mean Function Activities (Modified Brief Pain Inventory)
Assessment method [4] 0 0
In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)
Timepoint [4] 0 0
1 to 5 days post-dose

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2007
Sample size
Target
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
- Cairns
Recruitment hospital [2] 0 0
- Sunnybank
Recruitment hospital [3] 0 0
- Port Lincoln
Recruitment hospital [4] 0 0
- Ringwood East
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
4109 - Sunnybank
Recruitment postcode(s) [3] 0 0
5606 - Port Lincoln
Recruitment postcode(s) [4] 0 0
3135 - Ringwood East
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Durect
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Nycomed
Country [1] 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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 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

TypeCitations or Other Details
Journal Hadj A, Hadj A, Hadj A, Rosenfeldt F, Nicholson D,... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00974350