Prialt (Ziconotide) In Severe Chronic Pain
Pain
About this trial
This is an interventional treatment trial for Pain focused on measuring pain, ziconotide, Prialt, intrathecal, Synchromed
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Tennesee Valley Pain Consultants - Center For Pain Management
- The Pain Center
- Outcomes Research International
- The RC Goodman Pain Institute: Clinical Research
- Hot Springs Mercy Pain Clinic
- Innovative Spine Care
- Advanced Pain Medicine
- Advanced Pain Institute
- UCSD Medical Center, Thornton Hospital
- Abaci and Massey Pain Center
- UCSF Pain Management Center
- Pain Care Specialists
- Clinical Pharmacology Services, Inc.
- Georgia Medical Research Institute
- Rush Presbyterian - St. Luke's Medical Center
- University of Kentucky, Dept Anesthesiology
- Johns Hopkins Hospital, Division of Pain Management
- Arnold Pain Management
- Edina Medical Pain Center
- Research Medical Center - Pain Institute
- Yellowstone Medical Center East
- Huntington Center for Pain Treatment
- Weill Medical College of Cornell University
- Medical Pain Management of Central NY
- Center For Clinical Research
- The Cleveland Clinic Foundation
- Pain Institute of Tulsa
- Pain Consultants of Oregon
- Legacy Holladay Park Medical Center
- Penn State University Hospital
- Allegheny General Hospital
- Advanced Clinical Concepts
- Neurosurgery Foundation
- MUSC, Neurological Surgery
- Methodist Comprehensive Pain Institute
- Clinical Research Associates, Inc.
- University of Texas M.D. Anderson Cancer Center
- Texas Tech University HSC
- Consultants in Pain Research
- Alpine Pain and Addiction Medicine
- Advanced Pain Management and Rehabilitation
- University of Washington Medical Center - Pain Center
- Center for Pain Relief
- Cardinal Clinical Research Center