Prialt (Ziconotide) In Severe Chronic Pain
- Conditions
- Pain
- Registration Number
- NCT00047749
- Lead Sponsor
- Elan Pharmaceuticals
- Brief Summary
The purpose of this study is to understand the effects of intrathecal ziconotide (an experimental pain medication) when the dose is slowly increased over a 3-week period in patients with severe chronic pain. During the weaning phase, the study will also gather information about switching from other intrathecal or IT medication (slowly pumped directly into the space around the spine) to other systemic pain medication (by mouth or through the skin using a patch). After being weaned off current IT medication, patients will be placed on IT ziconotide or placebo (non-active substance) as well as being allowed a stable dose of systemic pain medications.
Patients who complete this study may be eligible for long-term ziconotide therapy via extension protocol ELN92045-352.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- Patient is able to read, understand, and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document prior to the performance of any study-specific procedures;
- 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.
- Patient is pregnant or lactating;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
Tennesee Valley Pain Consultants - Center For Pain Management
🇺🇸Huntsville, Alabama, United States
Abaci and Massey Pain Center
🇺🇸Los Gatos, California, United States
Pain Care Specialists
🇺🇸Colorado Springs, Colorado, United States
Hot Springs Mercy Pain Clinic
🇺🇸Hot Springs, Arkansas, United States
Medical Pain Management of Central NY
🇺🇸Syracuse, New York, United States
Advanced Pain Institute
🇺🇸Duarte, California, United States
UCSD Medical Center, Thornton Hospital
🇺🇸La Jolla, California, United States
Yellowstone Medical Center East
🇺🇸Billings, Montana, United States
Center For Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Georgia Medical Research Institute
🇺🇸Marietta, Georgia, United States
Outcomes Research International
🇺🇸Tucson, Arizona, United States
Edina Medical Pain Center
🇺🇸Edina, Minnesota, United States
The Pain Center
🇺🇸Northport, Alabama, United States
Advanced Pain Management and Rehabilitation
🇺🇸Virginia Beach, Virginia, United States
Pain Consultants of Oregon
🇺🇸Eugene, Oregon, United States
Advanced Pain Medicine
🇺🇸Bakersfield, California, United States
Research Medical Center - Pain Institute
🇺🇸Kansas City, Missouri, United States
Huntington Center for Pain Treatment
🇺🇸Huntington, New York, United States
MUSC, Neurological Surgery
🇺🇸Charleston, South Carolina, United States
The RC Goodman Pain Institute: Clinical Research
🇺🇸Fort Smith, Arkansas, United States
Texas Tech University HSC
🇺🇸Lubbock, Texas, United States
Cardinal Clinical Research Center
🇺🇸Cudahy, Wisconsin, United States
Neurosurgery Foundation
🇺🇸Providence, Rhode Island, United States
Advanced Clinical Concepts
🇺🇸Temple, Pennsylvania, United States
Pain Institute of Tulsa
🇺🇸Tulsa, Oklahoma, United States
Penn State University Hospital
🇺🇸Hershey, Pennsylvania, United States
Clinical Pharmacology Services, Inc.
🇺🇸Tampa, Florida, United States
Rush Presbyterian - St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
UCSF Pain Management Center
🇺🇸San Francisco, California, United States
Johns Hopkins Hospital, Division of Pain Management
🇺🇸Baltimore, Maryland, United States
Arnold Pain Management
🇺🇸Boston, Massachusetts, United States
Legacy Holladay Park Medical Center
🇺🇸Portland, Oregon, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Texas M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Consultants in Pain Research
🇺🇸San Antonio, Texas, United States
University of Washington Medical Center - Pain Center
🇺🇸Seattle, Washington, United States
Innovative Spine Care
🇺🇸Little Rock, Arkansas, United States
University of Kentucky, Dept Anesthesiology
🇺🇸Lexington, Kentucky, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Alpine Pain and Addiction Medicine
🇺🇸Salt Lake City, Utah, United States
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Center for Pain Relief
🇺🇸Charleston, West Virginia, United States
Methodist Comprehensive Pain Institute
🇺🇸Memphis, Tennessee, United States