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

Sponsors

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
Condition
Intervention

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

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

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

Australia

New Zealand

Verification Date

2021-05-01

Responsible Party

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

Organization: Durect Corporation

Keywords
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)

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 [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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