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
220 participants
INTERVENTIONAL
2002-08-31
2003-06-30
Brief Summary
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Patients who complete this study may be eligible for long-term ziconotide therapy via extension protocol ELN92045-352.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Interventions
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Prialt (ziconotide)
Eligibility Criteria
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Inclusion Criteria
* Patient must be male or female at least 18 years of age;
* Patient must have severe chronic pain for whom IT therapy is warranted;
* Patient must be willing and able to comply with the protocol, and able to maintain the Patient Daily Diary for Opioid Consumption;
* Patient must have an implanted programmable SynchroMed® Infusion System in place for the treatment of chronic pain;
* Female patients of childbearing age agree to use adequate, appropriate contraceptive methods.
Males and their partner(s) of childbearing age must use adequate, appropriate contraceptive methods.
Exclusion Criteria
* Patient has been on an investigational drug other than ziconotide or device within 30 days prior to the initiation of the study drug;
* Patients with a known hypersensitivity (allergy) to ziconotide or any of the excipients (other compounds) in the formulation;
* Patient has a condition that would contraindicate the use of IT analgesia, including the presence of infection at the microinfusion injection site (where the needle is inserted in your abdomen to fill the pump with medication), uncontrolled bleeding diathesis (tendency for bleeding) and spinal canal obstruction that impairs circulation of Cerebral Spinal Fluid.
18 Years
ALL
No
Sponsors
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Elan Pharmaceuticals
INDUSTRY
Locations
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Tennesee Valley Pain Consultants - Center For Pain Management
Huntsville, Alabama, United States
The Pain Center
Northport, Alabama, United States
Outcomes Research International
Tucson, Arizona, United States
The RC Goodman Pain Institute: Clinical Research
Fort Smith, Arkansas, United States
Hot Springs Mercy Pain Clinic
Hot Springs, Arkansas, United States
Innovative Spine Care
Little Rock, Arkansas, United States
Advanced Pain Medicine
Bakersfield, California, United States
Advanced Pain Institute
Duarte, California, United States
UCSD Medical Center, Thornton Hospital
La Jolla, California, United States
Abaci and Massey Pain Center
Los Gatos, California, United States
UCSF Pain Management Center
San Francisco, California, United States
Pain Care Specialists
Colorado Springs, Colorado, United States
Clinical Pharmacology Services, Inc.
Tampa, Florida, United States
Georgia Medical Research Institute
Marietta, Georgia, United States
Rush Presbyterian - St. Luke's Medical Center
Chicago, Illinois, United States
University of Kentucky, Dept Anesthesiology
Lexington, Kentucky, United States
Johns Hopkins Hospital, Division of Pain Management
Baltimore, Maryland, United States
Arnold Pain Management
Boston, Massachusetts, United States
Edina Medical Pain Center
Edina, Minnesota, United States
Research Medical Center - Pain Institute
Kansas City, Missouri, United States
Yellowstone Medical Center East
Billings, Montana, United States
Huntington Center for Pain Treatment
Huntington, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Medical Pain Management of Central NY
Syracuse, New York, United States
Center For Clinical Research
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Pain Institute of Tulsa
Tulsa, Oklahoma, United States
Pain Consultants of Oregon
Eugene, Oregon, United States
Legacy Holladay Park Medical Center
Portland, Oregon, United States
Penn State University Hospital
Hershey, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Advanced Clinical Concepts
Temple, Pennsylvania, United States
Neurosurgery Foundation
Providence, Rhode Island, United States
MUSC, Neurological Surgery
Charleston, South Carolina, United States
Methodist Comprehensive Pain Institute
Memphis, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Texas Tech University HSC
Lubbock, Texas, United States
Consultants in Pain Research
San Antonio, Texas, United States
Alpine Pain and Addiction Medicine
Salt Lake City, Utah, United States
Advanced Pain Management and Rehabilitation
Virginia Beach, Virginia, United States
University of Washington Medical Center - Pain Center
Seattle, Washington, United States
Center for Pain Relief
Charleston, West Virginia, United States
Cardinal Clinical Research Center
Cudahy, Wisconsin, United States
Countries
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Related Links
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Ziconotide in severe chronic pain (search using ziconotide)
Other Identifiers
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ELN92045-301
Identifier Type: -
Identifier Source: org_study_id