A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair

May 5, 2021 updated by: Durect

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Cairns, Queensland, Australia, 4870
      • Sunnybank, Queensland, Australia, 4109
    • South Australia
      • Port Lincoln, South Australia, Australia, 5606
    • Victoria
      • Ringwood East, Victoria, Australia, 3135
  • New Zealand
      • Hamilton, New Zealand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: SABER-Bupivacaine
2.5 mL SABER-Bupivacaine/Once
Drug: SABER-Bupivacaine
Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
Other Names:
  • POSIMIR® bupivacaine solution
Drug: SABER-Bupivacaine
Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once
Experimental: Group 2: SABER-Bupivacaine
5.0 mL SABER-Bupivacaine/Once
Drug: SABER-Bupivacaine
Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
Other Names:
  • POSIMIR® bupivacaine solution
Drug: SABER-Bupivacaine
Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once
Placebo Comparator: Group 3: SABER-Placebo
2.5 mL or 5.0 mL SABER-Placebo/Once
Drug: SABER-Placebo
Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity on Movement
Time Frame: 1 to 72 hours post-dose
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.
1 to 72 hours post-dose
Proportion (Percent) of Patients Using Supplemental Opioids
Time Frame: 0 to 14 days post-dose
0 to 14 days post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 1 to 48 hours post-dose
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.
1 to 48 hours post-dose
Treatment Satisfaction
Time Frame: 1 to 5 days post-dose
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).
1 to 5 days post-dose
Supplemental Opioid Use
Time Frame: 0 to 14 days post-dose
0 to 14 days post-dose
Mean Function Activities (Modified Brief Pain Inventory)
Time Frame: 1 to 5 days post-dose
In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)
1 to 5 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Durect

Collaborators

Nycomed

Investigators

  • Study Director: Dmitri Lissin, MD, Durect

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 8, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Actual)

May 27, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN803-006-0006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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