NCT01788605Unknown2 期
Prospective, Single-arm Phase 2 Trial to Evaluate Efficacy and Safety of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation for Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- efficacy of ramosetron in terms of complete response (no emesis, no rescue therapy) during the conditioning regimen and within 3 or 6 days after the end of the conditioning regimen
研究概览
简要总结
- The purpose of this study is to determine the efficacy of ramosetron for the prevention of emesis and the control of nausea and vomiting despite of the prophylactic antiemetic treatment during hematopoietic stem cell transplantation
- The study hypothesis is that ramosetron is effective for the prevention of emesis and control of emesis and/or vomiting that develop after the prophylactic antiemetic therapy in the setting of hematopoietic stem cell transplantation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients undergoing hematopoietic stem cell transplantation conditioned with highly or moderately emetogenic drugs or total body irradiation (TBI) for hematologic malignancies
- •aged over 18 yrs
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- •patients who are able to take oral medications
- •patients who get well-informed and sign the consent
排除标准
- •Patients complicating
- •severe hypertension (systolic blood pressure > 210 mmHg or diastolic blood pressure > 120 mmHg)
- •significant heart disease such as congestive heart failure
- •renal insufficiency (serum Cr >= 3.0 mg/dL)
- •liver disease (Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3 upper normal limit; alkaline phosphatase (ALP) > 2 upper normal limit)
- •Patients complicated by conditions such as gastrointestinal obstruction or active peptic ulcer causing emesis
- •Patients with brain tumor, brain metastasis and epilepsy
- •Patients with the history of extrapyramidal symptom
- •Patients with the history of allergy to serotonin antagonists
- •pregnant or lactating women
- •Patients with drug abuse or psychiatric illness, or patients who are not capable of the normal communications
研究组 & 干预措施
ramosetron
Experimental
干预措施: ramosetron (Drug)
结局指标
主要结局
efficacy of ramosetron in terms of complete response (no emesis, no rescue therapy) during the conditioning regimen and within 3 or 6 days after the end of the conditioning regimen
时间窗: within 1 week after the end of conditioning regimen
次要结局
- the efficacy of second dose of ramosetron for the treatment of breakthrough emesis(within 1 week after the end of conditioning regimen)
研究者
Ki-Seong Eom, MD
Associate Professor
The Catholic University of Korea
研究点 (1)
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