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

Sponsor:	Durect
Collaborator:	Nycomed
Information provided by:	Durect
ClinicalTrials.gov Identifier:	NCT00974350

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Hernia Surgery

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

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
Group 1: SABER™-Bupivacaine: Experimental 2.5 mL SABER™-Bupivacaine /Once	Drug: SABER™-Bupivacaine Injectable Extended Release Solution; 2.5 mL SABER™-Bupivacaine/Once
Group 2: SABER™-Bupivacaine: Experimental 5.0 mL SABER™-Bupivacaine /Once	Drug: SABER™-Bupivacaine Injectable Extended Release Solution; 5.0 mL SABER™-Bupivacaine/Once
Group 3: SABER™-Placebo: Placebo Comparator 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

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

Locations

Australia, Queensland

Sunnybank, Queensland, Australia, 4109

Cairns, Queensland, Australia, 4870
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

No publications provided

Responsible Party:	Durect Corporation ( Dmitri Lissin, MD, Sr. Director Clinical Research )
Study ID Numbers:	CLIN803-006-0006
Study First Received:	September 8, 2009
Last Updated:	December 21, 2009
ClinicalTrials.gov Identifier:	NCT00974350 History of Changes
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:

Pathological Conditions, Anatomical
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pain
Anesthetics, Local
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes

Postoperative Complications
Sensory System Agents
Therapeutic Uses
Hernia
Bupivacaine
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative

ClinicalTrials.gov processed this record on February 08, 2010