NCT02268812

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

Patient Registry of Intrathecal Pain Management in Europe: An Open-label, Long-term, Multi-center, Multi-national Post-marketing Observational Study of the Use of Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 219 (actual)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2008-04-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2014-10-20
• Last updated: 2018-10-25
• Results posted: 2018-10-25