Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain
NCT ID: NCT00076544
Last Updated: 2015-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2004-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Interventions
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Ziconotide
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Elan Pharmaceuticals
INDUSTRY
Locations
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Alabama Pain Center
Huntsville, Alabama, 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
The RC Goodman Pain Institute
Fort Smith, Arkansas, United States
Innovative Spine Care
Little Rock, Arkansas, United States
Shreenath Clinical Services
Beverly Hills, California, United States
Advanced Pain Institute
Duarte, California, United States
Shreenath Clinical Services
Lake Forest, California, United States
Shreenath Clinical Services
Long Beach, California, United States
Bay Area Pain Center
Los Gatos, California, United States
Northridge Surgery & Pain Management Center
Northridge, California, United States
Pacific Pain Medicine Consultants
Oceanside, California, United States
Pacific Pain Treatment Centers
San Francisco, California, United States
Galileo Surgery Center
San Luis Obispo, California, United States
Pain Relief Center of Colorado
Arvada, Colorado, United States
Pain Care Specialists
Colorado Springs, Colorado, United States
Rocky Mountain Clinical Research
Golden, Colorado, United States
Comprehensive Pain and Headache Treatment Centers, LLC
Derby, Connecticut, 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
Sarasota Pain Associates
Sarasota, Florida, United States
Clinical Pharmacology Services
Tampa, Florida, United States
Shepherd Center, Inc.
Atlanta, Georgia, United States
Comprehensive Pain Care, PC
Marietta, Georgia, United States
The University of Chicago, Dept. of Surgery, Section of Neurosurgery
Chicago, Illinois, United States
Indianapolis Neurosurgical Group
Indianapolis, Indiana, United States
University of Iowa Health Care
Iowa City, Iowa, United States
Des Moines Orthopedic Surgeons
West Des Moines, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Pain Control Network, PSC/PCN Surgical Suites, LLC
Louisville, Kentucky, United States
Wayne State University - School of Medicine
Detroit, Michigan, United States
Medical Advanced Pain Specialists (MAPS)
Minneapolis, Minnesota, United States
The Center for Pain Medicine
Hattiesburg, Mississippi, United States
Pain Management Associates, Clinical Research
Independence, Missouri, United States
St. John's Regional Healthcare
Springfield, Missouri, United States
Pain Management - Anesthesiology
Las Vegas, Nevada, United States
Dr. O'Connell's Pain Care Centers, Inc.
Somersworth, New Hampshire, United States
All Island Pain Consultants
Bay Shore, New York, United States
Cohn Pain Management Center
Bethpage, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
NYU Pain Management Center
New York, New York, United States
New York Presbyterian Hospital/Cornell Medical Center
New York, New York, United States
Medical Pain Management of Central New York
Syracuse, New York, United States
Duke Medical Center Pain Clinic
Durham, North Carolina, 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
Pain Management Consultants, PC
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Magee Rehabilitation
Philadelphia, Pennsylvania, United States
Carolinas Center for Advanced Management of Pain
Spartanburg, South Carolina, United States
Avera St. Luke's Hospital
Aberdeen, South Dakota, United States
Dallas Spine Care P.A.
Dallas, Texas, United States
Advanced Pain Medicine
Dallas, Texas, United States
The University of Texas Medical Branch
Galveston, Texas, United States
International Pain Institute
Lubbock, Texas, United States
American Pain & Wellness, PA
Plano, Texas, 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
Pain Management Center, University of Virginia
Charlottesville, Virginia, United States
The Center for Pain Relief
Charleston, West Virginia, United States
Countries
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Other Identifiers
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ELN92045-501
Identifier Type: -
Identifier Source: org_study_id