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

Completed

Conditions: Severe Chronic Pain
Pain Management

Registration Number: NCT02268812

Lead Sponsor: Eisai Limited

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 219

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI)	Month 8 (Visit 4), Month 12 (Visit 5), and Termination Visit (12 months after last participant was enrolled)	VASPI is a worldwide validated measure of pain intensity. A Visual Analog Score (VAS) for pain is determined by using a horizontal line, 100-millimeter (mm) in length, anchored by word descriptors at each end; "no pain" (0 mm) on the left end and "worst imaginable pain" (100 mm) on the right end. The participant was asked to mark on the line the point that they feel represents their current state of pain. A VAS for least pain (over last two weeks), usual pain (over last two weeks), and pain today was determined and averaged to derive the total VAS score ranging from 0 (no pain) to 100 (worst pain imaginable). A last observation carried forward (LOCF) dataset was used to account for missing data where First Visit data could be carried forward.

Secondary Outcome Measures

Name	Time	Method
Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Termination Visit	Baseline (Visit 1) to Termination Visit (12 Months after last participant was enrolled)	The BPI-SF survey is made up of two dimensions: pain intensity/severity and pain interference, with each dimension containing specific items that are graded (e.g. mood, walking ability, relations with other people, enjoyment of life, etc.). Each item was graded on an 11-point Likert scale. The pain intensity/severity survey was used to measure pain severity, where 0 was "no pain" and 10 was "pain as bad as you can imagine" for each item listed. The pain interference survey scored each item on a scale, where 0 was "does not interfere" to 10 was "completely interferes". The change in pain severity and pain interference from Baseline (Visit 1) were calculated from the scores.
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)	From first dose up to 30 days after the last dose of study treatment, for up to approximately 4 years 4 months.	Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events (SAEs), any therapeutic interventions including all drug therapies, vital signs, and creatine kinase (CK) if laboratory tests were taken by the physician as part of routine clinical practice. AEs were graded on a 3-point scale; 1) mild - discomfort noticed, but no disruption of normal daily activity, 2) moderate - discomfort sufficient to reduce or affect normal daily activity, 3) severe - incapacitating, with inability to work or to perform normal daily activity. A TEAE was defined as an adverse event (AE) with a start date on or after the date of the First Visit. Where a start date was missing, the AE was considered to be treatment-emergent.
Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Month 12 (Visit 5)	Baseline (Visit 1) to Month 12 (Visit 5)	The Brief Pain Inventory-Short Form (BPI-SF) survey is made up of two dimensions: pain intensity/severity and pain interference, with each dimension containing specific items that are graded (e.g. mood, walking ability, relations with other people, enjoyment of life, etc.). Each item was graded on an 11-point Likert scale. The pain intensity/severity survey was used to measure pain severity, where 0 was "no pain" and 10 was "pain as bad as you can imagine" for each item listed. The pain interference survey scored each item on a scale, where 0 was "does not interfere" to 10 was "completely interferes". The change in pain severity and pain interference from Baseline (Visit 1) were calculated from the scores.