NCT01888120已完成不适用
Patient Registry of Intrathecal Ziconotide Management (PRIZM): An Open-Label, Long Term, Multi-Center, Observational Study of PRIALT® (Ziconotide) Solution, Intrathecal Infusion, in Patients With Severe Chronic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 42
- 主要终点
- The effectiveness of PRIALT therapy for the management of severe chronic pain as evidenced by change in patient-reported pain intensity from baseline to 12 weeks after enrollment
研究概览
简要总结
The objectives of this study are to evaluate the effectiveness, long-term safety, tolerability, satisfaction with treatment, and health-related quality of life (HRQoL) associated with Intrathecal PRIALT use for severe chronic pain of varying etiologies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient is at least 18 years of age at the time of study entry.
- •Patient who has severe chronic pain, whom IT therapy is warranted, and who is intolerant of, or refractory to other treatments, such as systemic analgesics, adjunctive therapies, and/or IT morphine.
- •Patient is planned to be initiated on IT PRIALT as the sole agent in the pump at a participated site.
- •Patient has not received PRIALT treatment administered continuously via Medtronic SynchroMed® II pump within the past 30 days.
- •Patient has a life expectancy >6 months as determined by the physician.
- •Patient is able to read, understand, and voluntarily sign the IRB-approved informed consent document prior to the performance of any study-specific procedures.
- •Patient is able to understand and complete required assessments.
排除标准
- •Patient has a known hypersensitivity to PRIALT or any of its formulation components.
- •Patient has a pre-existing history of psychosis.
- •Patient has infection at the microinjection site, uncontrolled bleeding diathesis, or known spinal canal obstruction that impairs circulation of cerebrospinal fluid.
- •Patient is being initiated with PRIALT in conjunction with other IT agents.
- •Patients with any other concomitant treatment or medical condition that, in the opinion of the clinician, would render IT administration hazardous.
研究组 & 干预措施
Severe Chronic Pain
干预措施: Ziconotide (Drug)
结局指标
主要结局
The effectiveness of PRIALT therapy for the management of severe chronic pain as evidenced by change in patient-reported pain intensity from baseline to 12 weeks after enrollment
时间窗: 12 Weeks
次要结局
- The use of PRIALT in current clinical practice including dose at initiation, titration speed, effective dose, duration of treatment effect, use of other pain medications, etc.(From week 12, every 3 months up to month 18)
- Evaluate the following from the patient's perspective via patient reported outcomes (PROs)(From week 12, every 3 months up to month 18)
- Evaluate the patient's global impression of change (PGIC) with PRIALT treatment(From week 12, every 3 months up to month 18)
- Evaluate changes in concomitant pain medication use(From week 12, every 3 months up to month 18)
- Evaluate long-term safety and tolerability data, including incidence and severity of adverse events (AEs) and serious adverse events (SAEs)(From week 12, every 3 months up to month 18)
研究者
研究点 (42)
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