Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain intensity (Visual Analogue Scale; VAS Score)
研究概览
简要总结
This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its potential reversion by Pregabalin; (3) assessing quality of life of patients treated with pregabalin in comparison to placebo; (4) to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5) to compare anxiety and depression in patients treated with pregabalin in comparison to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years old recently diagnosed of pancreatic cancer (<3 months).
- •Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
- •Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
排除标准
- •Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- •Patients with previously diagnosed moderate to severe renal impairment. Those with a Clearance of Creatinine (CLcr) < 60mL/min should be excluded.
- •Patients treated with anticonvulsants during the previous 4 months.
研究组 & 干预措施
Group I
Conventional analgesic treatment + pregabalin.
干预措施: Pregabalin (Drug)
Group II
Conventional analgesic treatment + placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain intensity (Visual Analogue Scale; VAS Score)
时间窗: From baseline to day 90.
Analgesic effect of pregabalin therapy in pancreatic cancer patients, assessed using a visual analogue scale (VAS), the Brief Pain Inventory (BPI) and Neuropathic Pain VAS score.
次要结局
- Anxiety and depression(From baseline to day 90.)
- Quality of life(From baseline to day 90.)
- Performance status(From baseline until to day 90.)
- Neuropathic Pain(From baseline to day 90.)
研究者
CDursteler
MD, PhD
Parc de Salut Mar