NCT03546985已完成不适用
A Randomized, Multi-center, Single-use, Active-controlled, Open Study to Assess the Local Analgesic Effect of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Area under the curve (AUC) of pain score of oral mucositis
研究概览
简要总结
This is a randomized, multi-center, single-use, active-controlled, two-stage open study of episil®. The purpose of this study is to assess the local analgesic effect of episil® in cancer patients suffering from chemotherapy- and/or radiation-induced oral mucositis, which will provide scientific and reliable clinical data in the product registration in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male/female patient 18 years of age;
- •Pathological histologic and/or cytological diagnosis of malignant tumor;
- •Patients who are suffering from symptomatic oral mucositis (WHO grade 2 or above) during chemotherapy and/or radiotherapy during screening period;
- •Patients who are suffering from pain inside the oral cavity caused by oral mucositis, and pain assessment by Likert scale (0-10) results in a score of at least 6 out of 10 during screening period and at enrollment on Day 1;
- •Patients undergoing chemotherapy and/or radiotherapy: patients must have received at least one cycle of multiple-cycle chemotherapy regimen and/or have received multiple doses of radiation, prior to the enrollment on Day 1;
- •Patients at Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 and 3; and
- •Patients are able to provide written informed consent to participate in the study freely after the nature of the study and disclosure of data has been explained to the patients.
排除标准
- 未提供
研究组 & 干预措施
Group B
Active Comparator
干预措施: Kang Su (Device)
Group A
Experimental
干预措施: episil® (Device)
结局指标
主要结局
Area under the curve (AUC) of pain score of oral mucositis
时间窗: During 6 hours after a single use of investigational medical device
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
次要结局
- Incidence of adverse events(2 days)
- Peak pain intensity difference inside the oral cavity(During 6 hours after a single use of investigational medical device)
- Pain intensity decrease inside the oral cavity(During 6 hours after a single use of investigational medical device)
研究者
研究点 (7)
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