CTIS2023-507897-42-00招募中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 - BUL-5/ESD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 65+（—）
- 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; or 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, or b) = 75% oesophageal circumference in a patient with BE-HGD or EAC, Negative pregnancy test in females of childbearing potential at the screening visit;, Women of childbearing potential agree to apply during the entire duration of the trial an effective method of birth control, which is defined as those, which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly. Such methods include implants, injectables, combined oral contraceptive method, combined contraceptive patches and vaginal rings, copper containing IUDs, sexual abstinence, or vasectomised partner. The investigator is responsible for determining whether the patient applies adequate birth control methods to allow for trial participation. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or post-menopausal with at least two years without spontaneous menses.
排除标准
- •Any prior or intended chemotherapy for oesophageal cancer;, Any known relevant infectious disease (e.g., AIDS defining diseases, active tuberculosis);, Diagnosis of chickenpox, herpes zoster or measles within the last three months prior to randomisation, Known history of a) liver cirrhosis, b) severe renal impairment (Portugal only), Any of the following medical conditions (if not being sufficiently under control): cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, 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;, a) (All countries, except Portugal:) Any systemic therapy for any reason that may affect assessment of primary or secondary endpoints, i.e., biologics, or immunosuppressants, within the last 4 weeks prior to randomisation or planned as concomitant treatment, b) (Portugal only:) Any systemic therapy for any reason that may affect assessment of primary or secondary endpoints, i.e., systemic glucocorticosteroids, biologics, or immunosuppressants, within the last 4 weeks prior to randomisation or planned as concomitant treatment, a) (All countries, except Portugal:) Oral or intravenous systemic or oral topical glucocorticosteroids for any reason that may affect assessment of primary or secondary endpoints, which cannot be stopped at screening latest or are planned as concomitant treatment; b) (Portugal only:) Oral topical glucocorticosteroids used within the last 2 weeks prior to randomisation or planned as concomitant treatment, Inhaled or nasal topical glucocorticosteroids for any reason that may affect assessment of primary or secondary endpoints, which cannot be stopped at screening latest or are planned as concomitant treatment for more than 7 days;, Any therapy with cytochrome P450 3A4 (CYP3A4) inhibitors which might influence hepatic biotransformation: very potent (cobicistat, ritonavir, ketoconazole, voriconazole), potent (boceprevir, clarithromycin, itraconazole, saquinavir, telaprevir, telithromycin), or moderate (aprepitant, conivaptan, diltiazem, erythromycin, fluconazole, nefazodone, posaconazole, verapamil) administered repeatedly (i.e., > 3 days) in the last 3 weeks prior to randomisation or planned as concomitant therapy for more than 7 days;, Any therapy with CYP3A4 inducers, which might influence hepatic biotransformation: very potent (carbamazepine, phenytoin, rifampicin), moderate (St. John’s Wort), administered repeatedly (i.e., > 3 days) in the last 3 weeks prior to randomisation or planned as concomitant therapy for more than 7 days;, Any prior ESD in the area where ESD will be done;, Live vaccination within the last 4 weeks prior to randomisation, or any planned live vaccination during the trial, Intake of grapefruit containing food or beverages during the DB treatment phase, Known intolerance/hypersensitivity/resistance to the investigational medicinal product (IMP: budesonide) or its excipients or to drugs of similar chemical structure or pharmacological profile;, History of intolerance/hypersensitivity to propofol (if propofol will be used for sedation), Well-founded doubt about the patient’s cooperation, Existing or intended pregnancy or breast-feeding;, Participation in another clinical trial within the last 30 days prior to the screening visit,
研究者
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