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

Durect

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain; Surgery; Hernia

Treatments: Drug: SABER-Placebo; Drug: SABER-Bupivacaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00974350

CLIN803-006-0006

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 3 patient groups, including a placebo group

Group 1: SABER-Bupivacaine

Experimental group

Description:

2.5 mL SABER-Bupivacaine/Once

Treatment:

Drug: SABER-Bupivacaine

Drug: SABER-Bupivacaine

Group 2: SABER-Bupivacaine

Experimental group

Description:

5.0 mL SABER-Bupivacaine/Once

Treatment:

Drug: SABER-Bupivacaine

Drug: SABER-Bupivacaine

Group 3: SABER-Placebo

Placebo Comparator group

Description:

2.5 mL or 5.0 mL SABER-Placebo/Once

Treatment:

Drug: SABER-Placebo