Patient Registry of Intrathecal Ziconotide Management(PRIZM)
NCT ID: NCT01888120
Last Updated: 2017-03-16
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
93 participants
OBSERVATIONAL
2013-07-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Severe Chronic Pain
Ziconotide
Interventions
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Ziconotide
Eligibility Criteria
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Inclusion Criteria
* Patient who has severe chronic pain, whom IT therapy is warranted, and who is intolerant of, or refractory to other treatments, such as systemic analgesics, adjunctive therapies, and/or IT morphine.
* Patient is planned to be initiated on IT PRIALT as the sole agent in the pump at a participated site.
* Patient has not received PRIALT treatment administered continuously via Medtronic SynchroMed® II pump within the past 30 days.
* Patient has a life expectancy \>6 months as determined by the physician.
* Patient is able to read, understand, and voluntarily sign the IRB-approved informed consent document prior to the performance of any study-specific procedures.
* Patient is able to understand and complete required assessments.
Exclusion Criteria
* Patient has a pre-existing history of psychosis.
* Patient has infection at the microinjection site, uncontrolled bleeding diathesis, or known spinal canal obstruction that impairs circulation of cerebrospinal fluid.
* Patient is being initiated with PRIALT in conjunction with other IT agents.
* Patients with any other concomitant treatment or medical condition that, in the opinion of the clinician, would render IT administration hazardous.
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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I-Zu Huang, MD
Role: STUDY_DIRECTOR
Jazz Pharmaceuticals
Locations
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Tennessee Valley Pain Consultants
Huntsville, Alabama, United States
Valley Pain Specialists
Chandler, Arizona, United States
Desert Pain Institute
Mesa, Arizona, United States
Valley Pain Specialists
Scottsdale, Arizona, United States
White River Health System
Batesville, Arkansas, United States
United Pain Care
Sherwood, Arkansas, United States
Coastal Pain Research
Carlsbad, California, United States
Pain Therapy Solutions
Chino, California, United States
Pain Medicine Associates, Inc.
Fountain Valley, California, United States
University of California, San Diego
La Jolla, California, United States
Napa Pain Institute
Napa, California, United States
Cypress Ambulatory Surgery Center
Santa Maria, California, United States
Orthopedic Pain Specialists
Santa Monica, California, United States
Colorado Pain Clinic
Loveland, Colorado, United States
St. Francis Pain Center
Wilmington, Delaware, United States
Clearwater Pain Management
Clearwater, Florida, United States
Florida Pain Institute
Merritt Island, Florida, United States
AMPM Research Clinic
Miami, Florida, United States
Kennedy-White Orthopaedic Center
Sarasota, Florida, United States
JM Clinical Research
South Miami, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
Shepherd Center, Inc
Atlanta, Georgia, United States
Exodus Pain Clinic
Boise, Idaho, United States
Thompson and Chou Center for PM&R
Louisville, Kentucky, United States
Ana Pain Management
Clinton Township, Michigan, United States
Kozmary Center for Pain Management
Las Vegas, Nevada, United States
Spinal & Skeletal Pain Medicine
Utica, New York, United States
The Center for Clinical Research/Carolinas Pain Institute
Winston-Salem, North Carolina, United States
Integrated Pain Solutions
Columbus, Ohio, United States
Summa Health System Western Reserve Hospital
Cuyahoga Falls, Ohio, United States
Ashland Neurosurgery
Ashland, Oregon, United States
Cedar Sinai Medical Center
Ashland, Oregon, United States
OAG Interventional Pain Consultants
Portland, Oregon, United States
Oregon Anesthesiologist Group Interventional Pain Consultants
Portland, Oregon, United States
Einstein Physician Practice, Inc.
Elkins Park, Pennsylvania, United States
DNA Advanced Pain Treatment Center
Greensburg, Pennsylvania, United States
Houston Pain Associates
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Space City Pain Specialists LLP
Webster, Texas, United States
Advanced Spine and Pain
Stafford, Virginia, United States
The Center for Pain Relief
Charleston, West Virginia, United States
The Center of Pain Relief Tri-State
Huntington, West Virginia, United States
Anesthesia & Chronic Pain / University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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McDowell GC, Saulino MF, Wallace M, Grigsby EJ, Rauck RL, Kim P, Vanhove GF, Ryan R, Huang IZ, Deer T. Effectiveness and Safety of Intrathecal Ziconotide: Final Results of the Patient Registry of Intrathecal Ziconotide Management (PRIZM). Pain Med. 2020 Nov 1;21(11):2925-2938. doi: 10.1093/pm/pnaa115.
Deer T, Rauck RL, Kim P, Saulino MF, Wallace M, Grigsby EJ, Huang IZ, Mori F, Vanhove GF, McDowell GC 2nd. Effectiveness and Safety of Intrathecal Ziconotide: Interim Analysis of the Patient Registry of Intrathecal Ziconotide Management (PRIZM). Pain Pract. 2018 Feb;18(2):230-238. doi: 10.1111/papr.12599. Epub 2017 Jul 14.
Other Identifiers
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13-001
Identifier Type: -
Identifier Source: org_study_id
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