Multicenter Observational Study to Determine the Long-term Tolerability and Analgesic Effectiveness of Oral Tapentadol in Patients Suffering From Severe Pain Syndromes, Refractory to Other Strong Opioids.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 11
- 主要终点
- Difference in occurrence of gastrointestinal side effects (nausea, vomiting and constipation) between baseline and week 15
研究概览
简要总结
Multicenter observational study to determine the long-term tolerability and analgesic effectiveness of oral tapentadol in patients suffering from severe pain syndromes, refractory to other strong opioids.
详细描述
Tapentadol, a centrally acting analgesic. It is indicated in Europe "for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics" (IR formulation/oral solution) and "for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics" (SR formulation). Tapentadol is reimbursed in Belgium since May 1, 2018. The reimbursement was obtained through an article 81 procedure (Chapter IV) which means that the reimbursement is currently restricted to the time frame of the contract and that during that period certain questions and uncertainties regarding the use of tapentadol in a Belgian setting need to be answered. In order to answer the questions raised by the Belgian Healthcare authorities, this study will be performed evaluating the application of oral tapentadol in routine clinical practice in Belgium. The study is conceived as a nation-wide multicentre prospective non-interventional trial. The primary endpoint and secondary endpoints of this study are guided by the questions that need to be answered during the course of the contract reimbursement, as established by the Belgian health authorities.
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
- •Subjects should be capable of giving their informed consent;
- •Males and females, 18 years and older;
- •Patients suffering from severe pain;
- •Pain symptoms refractory to strong opioids (in previous treatment);
- •Due to side effects
- •Due to insufficient analgesic effectiveness
- •Due to opioid induced hyperalgesia.
排除标准
- •Severe renal and/or hepatic insufficiency;
- •Known and/or strong suspicion of allergy to tapentadol;
- •Previous treatment with tapentadol;
- •Presence of any condition for which tapentadol is contraindicated as per its approved labelling information in Belgium;
- •The patient has no access to a mobile phone and web browser. During the study, an online system is used to receive messages (SMS and e-mail) for the completing of the online assessments (through web browser).
结局指标
主要结局
Difference in occurrence of gastrointestinal side effects (nausea, vomiting and constipation) between baseline and week 15
时间窗: baseline - week 15
Differences in occurence of the PRO-CTCAE items: Nausea, vomiting and constipation
次要结局
- Change From Baseline in Pain Scores on the Numeric Rating Scale baseline to different time points during long-term follow-up(baseline - week 52)
- Change of health-related quality of life from baseline to different time points during long-term follow-up(baseline - week 52)
- Difference in frequency, severity and interference of selected side effects (dizziness, fatigue, itching, headache, dry mouth, nausea, vomiting, constipation) from baseline to week 52(baseline - week 52)
- Change of functional status of the patient from baseline to different time points during long-term follow-up(baseline - week 52)
- Drug conversion rates from other strong opioids to oral tapentadol from baseline to different time points during long-term follow-up(baseline - week 52)
- The occurrence of tolerance during oral tapentadol treatment from baseline to different time points during long-term follow-up(baseline - week 52)
研究者
Dafne Balemans
Clinical Trial Center UZA
University Hospital, Antwerp