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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 主要终点
- Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI)
时间窗: 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.
次要结局
- 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))
- 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.)
- 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))