The Evaluation of Targinact® in Daily Practice, With Regards to Pain Relief and Constipation, in Chronic Severe Pain Patients Compared to Previous Prolonged Release Oxycodone Treatment: a Non-interventional, Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Percentage of responders after Targinact treatment compared to the previous treatment with prolonged release oxycodone.
研究概览
简要总结
This non-interventional, observational study is set up on request of the Belgian reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief and constipation in daily clinical practice in Belgium compared to the previous analgesic treatment with prolonged release oxycodone. Only patients eligible for Targinact® reimbursement in Belgium are included.
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 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 with prolonged release oxycodone.
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
Percentage of responders after Targinact treatment compared to the previous treatment with prolonged release oxycodone.
时间窗: 12 weeks
A responder is defined as a patient who shows no worsening of pain (pain score has increased ≤ 1 unit on a 11-points pain NRS) at V3/the last visit compared to V1 or has a NRS ≤4 on a 11-points pain NRS at V3/the last visit AND has a reduction in BFI ≥ 12 units at V3/the last visit compared to V1 or has a BFI ≤30 at V3/ the last visit.
次要结局
- To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)(12 weeks)
- To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician)(12 weeks)
- To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)(12 weeks)
- To assess safety of Targinact® treatment (by physician)(12 weeks)