The Efficacy of Targinact® Treatment With Respect to Quality of Life (Overall Health Assessment) in Chronic Severe Pain Patients Compared to Previous Analgesic Treatment: a Non-interventional, Observational Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Assess the efficacy of Targinact® treatment
研究概览
简要总结
This non-interventional, observational study evaluates the efficacy of Targinact with regard to quality of life 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 during at least 12 weeks and are monitored during study 3 visits. Parameters assessed are overall health assessment of the patient, pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of Targinact® treatment. These parameters, except for safety assessment, are compared between Targinact® treatment and previous analgesic treatment.
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
研究组 & 干预措施
Targinact® (oxycodon/naloxon)
干预措施: Targinact® (oxycodon/naloxon) (Drug)
结局指标
主要结局
Assess the efficacy of Targinact® treatment
时间窗: 12 weeks
The primary parameter to assess the efficacy of Targinact® treatment with respect to the quality of life (overall health assessment/EQ-VAS) in patients with chronic severe pain compared to previous analgesic treatment is the absolute change in overall health score (0-100) attributed by patients during Targinact® treatment compared to previous analgesic treatment. During each visit, patients will be asked to score their overall health state between 0 (worst health state imaginable) and 100 (best health state imaginable). The absolute changes in overall health assessment from baseline at V2 and V3 will be used to compare health assessment during Targinact® treatment.
次要结局
- To assess safety of Targinact® treatment (by physician)(12 weeks)
- • To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)(12 weeks)
- To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)(12 weeks)
- To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)(12 weeks)
- To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)(12 weeks)
- To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient)(12 weeks)