The Efficacy, With Regard to Pain Relief, of Targinact® Treatment for Patients With Severe Pain Compared to Previous Analgesic Treatment; a Non-interventional Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,338
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain
研究概览
简要总结
This non-interventional, observational study evaluates the efficacy of Targinact with regard to pain relief in daily clinical practice in Belgium compared to the previous analgesic treatment.
详细描述
Patients are treated with Targinact® according to daily clinical practice and are monitored during 3 study visits. Parameters assessed are efficacy regarding pain relief, efficacy regarding bowel function, pain relief, use of analgesic rescue medication, bowel function, use of laxatives, safety of Targinact treatment, use of concomitant medication, patient satisfaction and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain
时间窗: Up to 140 days
Efficacy will be evaluated by the physician (7 categories). For the analysis the ordinal scale will be reduced to a binary scale: responder or non-responder. A responder is defined as a patient responding ''slightly better'', ''better'' or ''much better'' at any time during the Targinact®therapy. A non-responder is defined as a patient responding "same", "slightly worse", "worse", "much worse".
次要结局
- Bowel Function Index (BFI) will be recorded at each visit(Up to 140 days)
- The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded(Up to 140 days)
- Pain NAS score (0-10) will be measured at each visit(Up to 140 days)
- The use of laxative medication (yes/no) per 24 hours will be recorded in the e-CRF(Up to 140 days)
- Efficacy of Targinact® treatment, with regard to bowel function, will be evaluated by the physician (7 categories)(Up to 140 days)
- The patient's quality of life will be evaluated via the EQ-5D questionnaire(Up to 140 days)
- The patient satisfaction will be evaluated by patient in 7 categories(Up to 140 days)