NCT01842893已完成3 期
Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ethypharm
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Summed Pain Intensity Difference at 30 minutes (SPID30).
研究概览
简要总结
The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
Fentanyl / Placebo
Experimental
After an open-label titration to identify an optimal dose, patients were randomized to 1 of 13 prespecified sequences of 9 tablets (6 fentanyl and 3 placebo)
干预措施: Fentanyl Ethypharm (Drug)
结局指标
主要结局
Summed Pain Intensity Difference at 30 minutes (SPID30).
时间窗: 30 minutes post dose
次要结局
- Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing(3, 6, 10, 15, 30 and 60 minutes after dosing)
- Pain Relief at 3, 6, 10, 15, 30 and 60 minutes after dosing(3, 6, 10, 15, 30 and 60 minutes after dosing)
- The proportion of episodes of BTP that required rescue medication(15 and 30 minutes post dose)
- the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores(15 and 30 minutes post dose)
- SPID at 3, 6, 10, 15 and 60 minutes post-dosing(3, 6, 10, 15 and 60 minutes post-dosing)
- Recording of safety data(During all the study duration, an expected average of 8 weeks)
- SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive)(15 and 30 minutes post dose)
研究者
研究点 (1)
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Study placebo controlled to test the efficacy of Fentanyl Ethypharm for the treatment of exacerbated pains.Breakthrough pain related to cancer.MedDRA version: 14.1Level: LLTClassification code 10069398Term: Breakthrough cancer painSystem Organ Class: 10018065 - General disorders and administration site conditionsEUCTR2011-001140-30-CZaboratoires Ethypharm136
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