EUCTR2018-002617-35-DE进行中（未招募）1 期
Double-blind, randomised, placebo-controlled, phase IIa trial on the efficacy and tolerability of an 8-week treatment with two different doses of budesonide orodispersible tablets vs. placebo for prevention of oesophageal strictures in adult patients after endoscopic submucosal dissection - Budesonide orodispersible tablets vs. placebo to prevent oesophageal strictures after ESD
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed informed consent;
- •Male or female patients, 18 to 85 years of age;
- •Estimated life expectancy of at least one year (not applicable in Portugal);
- •ECOG Performance Status of = 2 at the randomisation visit (i.e. after the ESD-procedure);
- •a) Biopsy proven or endoscopically suspect oesophageal SCC and/or high grade dysplasia in a focal lesion of the squamous epithelium, treated with ESD;
- •b) Biopsy proven or endoscopically suspect BE-HGD or EAC, treated with ESD;
- •Mucosal defect after ESD of
- •a) = 50% oesophageal circumference in a patient with SCC,
- •b) = 75% oesophageal circumference in a patient with BE-HGD or EAC;
- •Negative pregnancy test in females of childbearing potential at the screening visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Any prior or intended chemotherapy for oesophageal cancer;
- •Any prior ESD in the area where ESD will be done;
- •Any prior or intended oesophageal surgery or surgery for the mediastinum, endoscopic mucosal resection (EMR), or radio frequency ablation (RFA), in the area where ESD will be done;
- •Evidence of regional lymph node metastases or distant metastases prior to ESD;
- •Any prior or intended radiotherapy which involves or affects the area of ESD during the last 5 years;
- •Any prior endoscopic dilation for oesophageal stenosis which involves or affects the area of ESD during the last 5 years;
- •Any other concomitant oesophageal disease;
- •Any severe concomitant disease, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results, or any disorder which in the opinion of the investigator might affect the patient's safety;
- •Any systemic therapy for any reason that may affect assessment of primary or secondary endpoints.
研究者
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