Status:
COMPLETED
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
Lead Sponsor:
Durect
Collaborating Sponsors:
Nycomed
Conditions:
Postoperative Pain
Hernia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00974350
Start Date
January 1 2007
End Date
October 1 2007
Last Update
May 27 2021
Active Locations (5)
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1
Cairns, Queensland, Australia, 4870
2
Sunnybank, Queensland, Australia, 4109
3
Port Lincoln, South Australia, Australia, 5606
4
Ringwood East, Victoria, Australia, 3135