Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.

NCT ID: NCT02268812

Last Updated: 2018-10-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 219 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2012-07-31

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 of life outcomes associated with ziconotide (Prialt) and other analgesics utilized in the intrathecal (IT) management of severe chronic pain.

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. 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).

Conditions

Pain Management; Severe Chronic Pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Ziconotide

No drug will be provided by the sponsor. Treatment decisions will be made by physicians independent of participation in the registry.

IT analgesia may consist of ziconotide or any other drug used in IT therapy, including those used off-label as part of local clinical practice.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SNX-111-E044-401

Identifier Type: -

Identifier Source: org_study_id