Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain
- Conditions
- Pain
- Registration Number
- NCT00076544
- Lead Sponsor
- Elan Pharmaceuticals
- Brief Summary
The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Each patient must have chronic severe pain of malignant or nonmalignant etiology with inadequate pain relief from or intolerance to conventional therapy.
- Each patient must have a predicted life expectancy of greater than or equal to 6 weeks relative to baseline.
- Each patient must be able to respond to the Visual Analog Scale of Pain Intensity (VASPI).
- Each patient must have an implanted programmable SynchroMed infusion device or a CADD-Micro external programmable infusion device and spinal catheter (hereafter "IT pump and spinal catheter") prior to enrollment into this trial. (If a patient has an external pump, the Investigator must ensure that the patient is at a low risk for infection and that the patient is capable of maintaining good personal hygiene. The Investigator must have demonstrated the ability to successfully manage patients with external pumps prior to enrolling a patient in this trial.)
- Each patient must be at least 18 years of age.
- Each patient must be competent to give written informed consent and has given written informed consent prior to performance of any study-related procedures. Reasonable accommodation of visually impaired patients will be allowed.
- Each patient is willing and able to comply with the protocol requirements.
- Each female patient of childbearing potential must agree to use adequate contraceptive methods while on PRIALT as determined by the Investigator.
- Presence of pregnancy or lactation.
- Participation in another investigational drug or device trial within the preceding 30 days.
- Presence of known hypersensitivity to PRIALT or any of its components.
- Presence of any contraindication to continued IT therapy (for example, infection at the pump or catheter externalization site, uncontrolled bleeding diathesis, spinal canal obstruction that impairs cerebrospinal fluid [CSF] circulation, or patient and caregiver inability to manage and protect the IT pump and spinal catheter system and return for clinic follow up visits).
- Presence of any condition (for example, psychosis, severe depression or suicidal ideation, homicidality, somatization disorder, active substance abuse, cognitive deficits, dementia or other serious medical or psychiatric condition) that in the Investigator's opinion precludes the patient's ability to participate in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (63)
The University of Chicago, Dept. of Surgery, Section of Neurosurgery
🇺🇸Chicago, Illinois, United States
The Center for Pain Relief
🇺🇸Charleston, West Virginia, United States
Alabama Pain Center
🇺🇸Huntsville, Alabama, United States
The RC Goodman Pain Institute
🇺🇸Fort Smith, Arkansas, United States
Center for Pain Management
🇺🇸Huntsville, Alabama, United States
Otto Uhrik, MD
🇺🇸Sun City West, Arizona, United States
Outcomes Research International
🇺🇸Tucson, Arizona, United States
Innovative Spine Care
🇺🇸Little Rock, Arkansas, United States
Advanced Pain Institute
🇺🇸Duarte, California, United States
Bay Area Pain Center
🇺🇸Los Gatos, California, United States
Shreenath Clinical Services
🇺🇸Long Beach, California, United States
Northridge Surgery & Pain Management Center
🇺🇸Northridge, California, United States
Pacific Pain Medicine Consultants
🇺🇸Oceanside, California, United States
Pain Relief Center of Colorado
🇺🇸Arvada, Colorado, United States
Galileo Surgery Center
🇺🇸San Luis Obispo, California, United States
Sarasota Pain Associates
🇺🇸Sarasota, Florida, United States
Florida Institute of Medical Research
🇺🇸Jacksonville, Florida, United States
Space Coast Pain Institute
🇺🇸Merritt Island, Florida, United States
West Gables Rehabilitation Hospital
🇺🇸Miami, Florida, United States
Pain Care Specialists
🇺🇸Colorado Springs, Colorado, United States
Comprehensive Pain Care, PC
🇺🇸Marietta, Georgia, United States
Shepherd Center, Inc.
🇺🇸Atlanta, Georgia, United States
Indianapolis Neurosurgical Group
🇺🇸Indianapolis, Indiana, United States
Des Moines Orthopedic Surgeons
🇺🇸West Des Moines, Iowa, United States
Pain Control Network, PSC/PCN Surgical Suites, LLC
🇺🇸Louisville, Kentucky, United States
The Center for Pain Medicine
🇺🇸Hattiesburg, Mississippi, United States
All Island Pain Consultants
🇺🇸Bay Shore, New York, United States
Pain Management Associates, Clinical Research
🇺🇸Independence, Missouri, United States
St. John's Regional Healthcare
🇺🇸Springfield, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Cohn Pain Management Center
🇺🇸Bethpage, New York, United States
Medical Pain Management of Central New York
🇺🇸Syracuse, New York, United States
NYU Pain Management Center
🇺🇸New York, New York, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Cincinnati Centers for Pain Relief, Inc.
🇺🇸Hamilton, Ohio, United States
PETC Research Group, Inc.
🇺🇸Tulsa, Oklahoma, United States
Pain Consultants of Oregon
🇺🇸Eugene, Oregon, United States
Magee Rehabilitation
🇺🇸Philadelphia, Pennsylvania, United States
Carolinas Center for Advanced Management of Pain
🇺🇸Spartanburg, South Carolina, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Dallas Spine Care P.A.
🇺🇸Dallas, Texas, United States
Advanced Pain Medicine
🇺🇸Dallas, Texas, United States
International Pain Institute
🇺🇸Lubbock, Texas, United States
The University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
American Pain & Wellness, PA
🇺🇸Plano, Texas, United States
Rocky Mountain Clinical Research
🇺🇸Golden, Colorado, United States
Pacific Pain Treatment Centers
🇺🇸San Francisco, California, United States
Wayne State University - School of Medicine
🇺🇸Detroit, Michigan, United States
Medical Advanced Pain Specialists (MAPS)
🇺🇸Minneapolis, Minnesota, United States
Duke Medical Center Pain Clinic
🇺🇸Durham, North Carolina, United States
Pain Management Consultants, PC
🇺🇸Portland, Oregon, United States
Consultants in Pain Research, PA
🇺🇸San Antonio, Texas, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States
University of Utah Pain Management Center
🇺🇸Salt Lake City, Utah, United States
Clinical Pharmacology Services
🇺🇸Tampa, Florida, United States
New York Presbyterian Hospital/Cornell Medical Center
🇺🇸New York, New York, United States
Avera St. Luke's Hospital
🇺🇸Aberdeen, South Dakota, United States
Comprehensive Pain and Headache Treatment Centers, LLC
🇺🇸Derby, Connecticut, United States
Pain Management - Anesthesiology
🇺🇸Las Vegas, Nevada, United States
Dr. O'Connell's Pain Care Centers, Inc.
🇺🇸Somersworth, New Hampshire, United States
Pain Management Center, University of Virginia
🇺🇸Charlottesville, Virginia, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Iowa Health Care
🇺🇸Iowa City, Iowa, United States