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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

Page last updated: August 23, 2015

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