Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
331 participants
INTERVENTIONAL
2009-12-31
2011-09-30
Brief Summary
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The purpose of this study is to investigate safety (side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active: SABER-Bupivacaine
SABER-Bupivacaine
SABER-Bupivacaine
Injectable Extended Release Solution; SABER-Bupivacaine /Once
Comparator: Bupivacaine HCl
Bupivacaine HCl
Bupivacaine HCl
Injectable Solution; Bupivacaine HCl /Once
Placebo: SABER-Placebo
SABER-Placebo
SABER-Placebo
Injectable Solution; SABER-Placebo/Once
Interventions
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SABER-Bupivacaine
Injectable Extended Release Solution; SABER-Bupivacaine /Once
Bupivacaine HCl
Injectable Solution; Bupivacaine HCl /Once
SABER-Placebo
Injectable Solution; SABER-Placebo/Once
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males and females, 18 years of age and older scheduled to undergo elective general abdominal surgery
* Patients must be healthy or have only mild systemic disease
* BMI \< 45
* Patients must have ECG wave form within normal limits
* Female and male patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial participation is completed
Exclusion Criteria
* Patients undergoing emergency surgery (unless full consent is obtained and all screening procedures are completed prior to surgery)
* Significant concomitant surgical procedure
* History of multiple prior laparotomy procedures
* Cancer with known metastases pre-operatively, which are suspected to impact post-operative recovery or pain
* Planned formation of stoma during surgery or plans to undergo another laparotomy procedure within 30 days post-operatively
* Pre-operative evidence of sepsis or septic shock
* Pre-operative evaluation that suggests a surgery may preclude full closure of the incision(s)
* Patients with current or regular use of systemic steroids, anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be withdrawn from these medications
* Patients with current or regular use of drugs known to significantly prolong the QTc interval
* Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g. lidocaine, bupivacaine)
* Patients with known hypersensitivity to morphine
* Patients with conditions contraindicated for use of opioids
* Patients with atrial fibrillation/flutter or other non-sinus rhythm (including paced rhythm); left bundle branch block (LBBB); or the following conditions: right bundle branch block (RBBB) in presence of a cardiac disease, significant cardiomyopathy, and myocardial infarction within last 6 months
* Patients with a serum creatinine level two times more than the local laboratory normal limit
* Patients who have received greater than 600 mg morphine equivalent daily dose for three or more days per week in the month prior to the surgical procedure
* Patients who are currently being treated with methadone, or history of methadone use within the previous 6 months
* Patients with known or suspected abuse of opioids or other illicit drugs
* Patients with known or suspected alcohol abuse
* Participation in another clinical trial at the same time or within 30 days of this trial
* Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason
18 Years
ALL
No
Sponsors
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Nycomed
INDUSTRY
Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
Durect
INDUSTRY
Responsible Party
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Principal Investigators
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Dmitri Lissin, MD
Role: STUDY_DIRECTOR
Durect
Locations
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DURECT Study Site
Birmingham, Alabama, United States
DURECT Study Site
Florence, Alabama, United States
DURECT Study Site
Mobile, Alabama, United States
DURECT Study Site
Mobile, Alabama, United States
DURECT Study Site
Montgomery, Alabama, United States
DURECT Study Site
Sheffield, Alabama, United States
DURECT Study Site
Arcadia, California, United States
DURECT Study Site
Fontana, California, United States
DURECT Study Site
Laguna Hills, California, United States
DURECT Study Site
Pasadena, California, United States
DURECT Study Site
Tampa, Florida, United States
DURECT Study Site
Powder Springs, Georgia, United States
DURECT Study Site
Indianapolis, Indiana, United States
DURECT Study Site
Boston, Massachusetts, United States
DURECT Study Site
Troy, Michigan, United States
DURECT Study Site
Duluth, Minnesota, United States
DURECT Study Site
New York, New York, United States
DURECT Study Site
Durham, North Carolina, United States
DURECT Study Site
Columbus, Ohio, United States
DURECT Study Site
Hershey, Pennsylvania, United States
DURECT Study Site
Houston, Texas, United States
DURECT Study Site
Temple, Texas, United States
DURECT Study Site
Woodville South, South Australia, Australia
DURECT Study Site
Box Hill, Victoria, Australia
DURECT Study Site
Ringwood East, Victoria, Australia
DURECT Study Site
Christchurch, , New Zealand
Countries
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Other Identifiers
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C803-025
Identifier Type: -
Identifier Source: org_study_id
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