Status:
COMPLETED
Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.
Lead Sponsor:
Eisai Limited
Conditions:
Pain Management
Severe Chronic Pain
Eligibility:
All Genders
18+ years
Brief Summary
This is an open-label, long-term, multi-center multi-national post-marketing observational registry. The objective of this study is to monitor the long-term efficacy, safety, tolerability and quality ...
Detailed Description
This is an observational non-interventional registry. All patients will sign and date an Informed Consent Form (ICF) before enrollment (Baseline Visit). Normal clinical practice will be followed. Pati...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients will be eligible to enroll onto the registry if they have given informed consent and meet the following criteria:
- Patient's physician has deemed that the initiation/switch of intrathecal analgesia appropriate, or patient is presently utilizing ziconotide (Prialt)
- Patient has a diagnosis of severe, chronic pain for which intrathecal infusion is indicated
- Patient is at least 18 years of age at time of study entry
- All patients starting ziconotide (Prialt) should comply with the indications and warnings in the current approved version of the Summary of Product Characteristics (SmPC).
- Exclusion Criteria
- Patients who meet any of the following criteria will not be eligible to enroll in the registry:
- Patient is a pregnant or lactating female
- Patient is receiving intrathecal chemotherapy
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT02268812
Start Date
April 1 2008
End Date
July 1 2012
Last Update
October 25 2018
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