Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.
Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain Management; Severe Chronic Pain
Phase: N/A
Status: Completed
Sponsored by: Eisai Limited
Summary
This is an open-label, long-term, multi-centre multi-national postmarketing observational
registry. The objective of this study is to monitor the long-term efficacy, safety,
tolerability and quality of life outcomes associated with Prialt and other analgesics
utilised in the intrathecal management of severe chronic pain.
Clinical Details
Official title: Patient Registry of Intrathecal Pain Management in Europe: An Open-label, Long-term, Multi-centre, Multi-national Post-marketing Observational Study of the Use of Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.
Study design: N/A
Primary outcome: Visual Analog Scale of Pain Intensity (VASPI)Changes in primary intrathecal drug, including dose adjustment and intervals Concomitant pain medications with dosage Safety and tolerability of Prialt as a measure of all adverse events/serious adverse events Quality of Life
Detailed description:
This is an obsevational non-interventional registry. All patients will sign and date an
Informed Consent Form (ICF) before enrolment (Baseline Visit). Normal clinical practice will
be followed. Patients will continue to follow their usual schedule of clinic visits as
determined by their physician, during which information and patient-completed questionnaires
will be collected (at scheduled intervals timed to coincide with pump refill). The
post-baseline assessment schedule is expected to be at 6 weeks, 4 months, and then every 4
months thereafter.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients will be eligible to enrol onto the registry if they have given informed consent
andmeet the following criteria:
- Patient's physician has deemed that the initiation/switch of intrathecal analgesia
appropriate, or patient is presently utilising 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 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 enrol in the
registry:
- Patient is a pregnant or lactating female
- Patient is receiving intrathecal chemotherapy
Locations and Contacts
Additional Information
Starting date: April 2008
Last updated: October 16, 2014
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