EUCTR2011-002557-56-HU进行中（未招募）不适用
A randomized, double-blind, parallel-group, placebo-controlled study to assess the clinical benefit of SSR411298 as adjunctive treatment for persistent cancer pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with moderate or severe, persistent cancer pain who are receiving World Health Organization (WHO) Step 2 or 3 cancer pain treatment (2) as Background Therapy (BT)
- •- Pain generator must be primarily due to underlying cancer or cancer treatment
- •- Pain generator must be classified as either primarily nociceptive or primarily neuropathic
- •- Pain severity must be moderate or severe, as defined as an NRS score of =4 during the SP [note: average NRS score = average pain intensity (not highest or lowest pain intensity) for each day of the SP, averaged over the SP]
- •- World Health Organization Step 2 or 3 cancer pain treatment as BT consists of opioids ± non-opioids ± adjuvants ± rescue therapy for breakthrough pain
- •+ For patients with primarily nociceptive cancer pain (NCCP), examples of permitted adjuvant pain treatments are corticosteroids, bisphosphonates, etc, with planned administration to be stable during the study
- •+ For patients with primarily neuropathic cancer pain (NPCP), examples of permitted adjuvant pain treatments are antidepressants or antiepileptics, etc, with planned administration to be stable during the study
- •-Dose adjustment of BT is permitted during the study but any change other than dose adjustment of BT is prohibited
- •Signed written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Instability of pain between Visit 1 (Day 7) and Visit 2 (Day 1)
- •Satisfied” or extremely satisfied” response on the 5-point Likert patient satisfaction of pain relief scale at Visit 1 (Day -7) or Visit 2 (Day -1)
- •Prohibited adjuvant pain treatments in the week prior to Visit 1 (Day 7) or planned administration during the study
- •- For patients with primarily NCCP, the prohibited adjuvant pain treatments are antidepressants or antiepileptics
- •- For patients with primarily NPCP, antidepressants or antiepileptics are permitted but the simultaneous use of both an antidepressant and antiepileptic is prohibited
- •Use of tetradydrocannabinol (THC) compounds for the treatment of pain
- •Chemotherapy within 4 weeks of Visit 1 (Day -7) or chemotherapy planned during the study (a stable regimen of hormonal therapy is permitted)
- •Radiotherapy within 4 weeks of Visit 1 (Day 7) or radiotherapy planned during the study (hemostatic palliative radiotherapy is permitted)
- •Cancer-related surgery within 4 weeks of Visit 1 (Day 7) or cancer-related surgery planned during the study
研究者
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