Patient Registry of Intrathecal Ziconotide Management(PRIZM)
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/2/2016 |
Start Date: | July 2013 |
Patient Registry of Intrathecal Ziconotide Management (PRIZM): An Open-Label, Long Term, Multi-Center, Observational Study of PRIALT® (Ziconotide) Solution, Intrathecal Infusion, in Patients With Severe Chronic Pain
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 PRIALT use for severe chronic pain of varying etiologies.
tolerability, satisfaction with treatment, and health-related quality of life (HRQoL)
associated with Intrathecal PRIALT use for severe chronic pain of varying etiologies.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
55
sites
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