NCT00642512已完成3 期
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Efficacy Study of Oral Dronabinol Alone and in Combination With Ondansetron Versus Ondansetron Alone in Subjects With Delayed Chemotherapy-Induced Nausea and Vomiting
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 43
- 主要终点
- Total response of nausea and vomiting/retching was defined as no vomiting and/or retching, an intensity of nausea of < 5 mm on the visual analog scale (VAS) and no use of rescue medication.
研究概览
简要总结
The primary purpose of the study is to determine the efficacy of oral dronabinol versus standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced nausea and vomiting (CINV) or retching by measuring the incidence of total response of nausea and vomiting and/or retching following administration of moderate-to-high emetogenic chemotherapeutic agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- •Histological evidence of non-CNS malignancy (primary or metastatic disease) and lymphomas which are not involving the bone marrow.
- •Undergoing single or multiple days of chemotherapy as long as Day 1 chemotherapy includes:
- •a moderate-to-high emetogenic regimen, or
- •oxaliplatin at doses employed for treatment of colon cancer, or
- •the combination of AC [AdriamycinÒ (60 mg/m2) with cyclophosphamide (600 mg/m2)] as to be used for the chemotherapeutic drug regimen involving taxanes in the treatment of breast cancer.
排除标准
- •Chemotherapy agents falling into the low (Level 1), moderate-to-low (Level 2), moderate (Level 3) unless used in combination with a Level 4 chemotherapy agent on Day 1 of the study.
- •Chemotherapy agents falling into the high (Level 5) classification during study.
- •Any combination of chemotherapy agents that does not fall into the moderate-to-high (Level 4) classification
研究组 & 干预措施
1
Experimental
干预措施: dronabinol (Drug)
2
Active Comparator
干预措施: ondansetron (Drug)
3
Other
干预措施: dronabinol/ondansetron (Drug)
4
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Total response of nausea and vomiting/retching was defined as no vomiting and/or retching, an intensity of nausea of < 5 mm on the visual analog scale (VAS) and no use of rescue medication.
时间窗: 5 days
次要结局
- Complete responder rate (no vomiting/retching, intensity of nausea of ≤ 30 mm on the VAS and no use of rescue medication)(5 days)
- Presence or absence of nausea(5 days)
- Episodes of vomiting and/or retching(5 days)
- Duration of nausea and vomiting and/or retching(5 days)
研究者
研究点 (43)
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