Status:
COMPLETED
Patient Registry of Intrathecal Ziconotide Management(PRIZM)
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Patients With Severe Chronic Pain
Eligibility:
All Genders
18+ years
Brief Summary
The objectives of this study are to evaluate the effectiveness, long-term safety, tolerability, satisfaction with treatment, and health-related quality of life (HRQoL) associated with Intrathecal PRIA...
Eligibility Criteria
Inclusion
- Patient is at least 18 years of age at the time of study entry.
- 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
- Patient has a known hypersensitivity to PRIALT or any of its formulation components.
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01888120
Start Date
July 1 2013
End Date
March 1 2017
Last Update
March 16 2017
Active Locations (43)
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1
Tennessee Valley Pain Consultants
Huntsville, Alabama, United States, 35801
2
Valley Pain Specialists
Chandler, Arizona, United States, 85224
3
Desert Pain Institute
Mesa, Arizona, United States, 85206
4
Valley Pain Specialists
Scottsdale, Arizona, United States, 85006