NCT01099891Unknown3 期
The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients
Daewoong Pharmaceutical Co. LTD.2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Incidence of severe oral mucositis (RTOG garde 3 or 4)
研究概览
简要总结
The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy
详细描述
Radiation therapy causes many side effects especially oral mucositis. The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy. Head and neck cancer patients who have a plan to receive a minimum of 50 Gy radiation therapy will be enrolled.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female, aged at least 18 years
排除标准
- •Females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential
- •Have oral mucositis or other oral conditions at study entry
研究组 & 干预措施
EGF
Experimental
干预措施: rhEGF (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of severe oral mucositis (RTOG garde 3 or 4)
时间窗: 5 weeks(at the point of receiving 50 Gy radiation)
次要结局
- Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis(5 weeks(at the point of receiving 50 Gy radiation))
- Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis(5 weeks(at the point of receiving 50 Gy radiation))
研究者
研究点 (2)
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