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

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


Lead Sponsor: Durect

Collaborator: Nycomed

Source Durect
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.

Overall Status Completed
Start Date 2007-01-01
Completion Date 2007-10-01
Primary Completion Date 2007-10-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Pain Intensity on Movement 1 to 72 hours post-dose
Proportion (Percent) of Patients Using Supplemental Opioids 0 to 14 days post-dose
Secondary Outcome
Measure Time Frame
Pain Intensity 1 to 48 hours post-dose
Treatment Satisfaction 1 to 5 days post-dose
Supplemental Opioid Use 0 to 14 days post-dose
Mean Function Activities (Modified Brief Pain Inventory) 1 to 5 days post-dose
Enrollment 124

Intervention Type: Drug

Intervention Name: SABER-Bupivacaine

Description: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once

Arm Group Label: Group 1: SABER-Bupivacaine

Intervention Type: Drug

Intervention Name: SABER-Bupivacaine

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

Arm Group Label: Group 2: SABER-Bupivacaine

Other Name: POSIMIR® bupivacaine solution

Intervention Type: Drug

Intervention Name: SABER-Placebo

Description: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once

Arm Group Label: Group 3: SABER-Placebo



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



Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:


Overall Official
Last Name Role Affiliation
Dmitri Lissin, MD Study Director Durect
| Cairns, Queensland, 4870, Australia
| Sunnybank, Queensland, 4109, Australia
| Port Lincoln, South Australia, 5606, Australia
| Ringwood East, Victoria, 3135, Australia
| Hamilton, New Zealand
Location Countries


New Zealand

Verification Date


Responsible Party

Name Title: Dmitri Lissin, MD, Sr. Director Clinical Research

Organization: Durect Corporation

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Group 1: SABER-Bupivacaine

Type: Experimental

Description: 2.5 mL SABER-Bupivacaine/Once

Label: Group 2: SABER-Bupivacaine

Type: Experimental

Description: 5.0 mL SABER-Bupivacaine/Once

Label: Group 3: SABER-Placebo

Type: Placebo Comparator

Description: 2.5 mL or 5.0 mL SABER-Placebo/Once

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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