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

This study has been completed.
Sponsor:
Collaborator:
Nycomed
Information provided by:
Durect
ClinicalTrials.gov Identifier:
NCT00974350
First received: September 8, 2009
Last updated: April 25, 2012
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Hernia
Surgery
Drug: SABER™-Bupivacaine
Drug: SABER™-Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Durect:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: 0 to 3 days post-dose ] [ Designated as safety issue: No ]
  • Proportion of patients using supplemental opioids [ Time Frame: 0 to 14 days post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Intensity [ Time Frame: 0 to 2 days post-dose ] [ Designated as safety issue: No ]
  • Treatment satisfaction [ Time Frame: 1 to 5 days post-dose ] [ Designated as safety issue: No ]
  • Supplemental opioid use [ Time Frame: 0 to 14 days post-dose ] [ Designated as safety issue: No ]
  • Mean function activities [ Time Frame: 1 to 5 days post-dose ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: January 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: SABER™-Bupivacaine
2.5 mL SABER™-Bupivacaine /Once
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974350

Locations
Australia, Queensland
Cairns, Queensland, Australia, 4870
Sunnybank, Queensland, Australia, 4109
Australia, South Australia
Port Lincoln, South Australia, Australia, 5606
Australia, Victoria
Ringwood East, Victoria, Australia, 3135
New Zealand
Hamilton, New Zealand
Sponsors and Collaborators
Durect
Nycomed
Investigators
Study Director: Dmitri Lissin, MD Durect Corporation
  More Information

Publications:
Responsible Party: Dmitri Lissin, MD, Sr. Director Clinical Research, Durect Corporation
ClinicalTrials.gov Identifier: NCT00974350     History of Changes
Other Study ID Numbers: CLIN803-006-0006
Study First Received: September 8, 2009
Last Updated: April 25, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe

Keywords provided by Durect:
Post-operative pain
hernia surgery
opioid

Additional relevant MeSH terms:
Hernia
Pain, Postoperative
Pain
Pathologic Processes
Pathological Conditions, Anatomical
Postoperative Complications
Signs and Symptoms
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014