NCT02210494Unknown1 期
Phase 1 Study of Safety of Secretrol® in the Short-term Management of Patients Undergoing Endoscopic Mucosal Resection (EMR)
Effexus Pharmaceutical1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2013年4月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Adverse effect evaluation
研究概览
简要总结
Evaluate the safety of Secretrol® in patients undergoing endoscopic mucosal resection for early adenocarcinoma of the esophagus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Category 4-high-grade intraepithelial neoplasia
- •Ages 18 or older
- •signed Informed Consent Form
- •signed Health Insurance Portability and Accountability Act (HIPAA) Authorization Form
排除标准
- •Clinically relevant data suggesting an unknown disease and requiring further evaluation by the Primary Investigator.
- •Patients with renal failure or organ transplants.
- •Patients who have known allergic reactions to Proton Pump Inhibitors (PPI).
- •Participation in another study that would interfere with study endpoints within 30 days prior to screening.
- •Previous enrollment into the current study.
- •Patient is the Investigator, his family member or employee at the investigational site.
- •Patient known or suspected to be involved in alcohol or drug abuse.
- •Known or suspected history of non-compliance with medications.
- •Inability to follow the procedures of the study (e.g., due to language problems, psychological disorders)
- •Patients receiving prohibited concomitant medications including PPIs, H2-blockers, sucralfate, misoprostol.
- •Patients receiving prohibited concomitant medications including clopidogrel, ketoconazole, digoxin, diazepam, warfarin, phenytoin, emtricitabine/nelfinavir/tenofovir, atazanavir, citalopram, emtricitabine/rilpivirine/tenofovir, rilpivirine, nelfinavir, tricyclic antidepressants, baclofen, tacrolimus, cyclosporine, cilostazol, disulfiram, methotrexate, voriconazole.
- •Pregnancy or intention to become pregnant during the course of study, breast feeding, or unwillingness to use a highly effective means of contraception (oral contraception or intrauterine device).
- •Prescription Non-steroidal anti-inflammatory Drug (NSAID) or aspirin use: The patient must be able to stop these meds 1 week prior to screening and during treatment.
- •History of upper gastrointestinal surgery, Zollinger-Ellison syndrome, esophageal stricture, peptic stricture, duodenal and ⁄ or gastric ulcer, esophageal motility disorders, Inflammatory Bowel Disease (IBD), AIDS, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, liver disease, active malignant disease, Scleroderma, diabetes mellitus, autonomic or peripheral neuropathy, myopathy, functional bowel disorder or any underlying disease or medication that might affect the lower esophageal sphincter pressure or increase the acid clearance time.
- •Subject unable or unwilling to fully complete all stages of the study.
- •Unable to sign informed consent or inability to give fully informed consent due to language problems, psychological disorder or mental deficiency.
研究组 & 干预措施
Secretrol
Experimental
干预措施: Secretrol (Drug)
结局指标
主要结局
Adverse effect evaluation
时间窗: 60 days
次要结局
未报告次要终点
研究者
研究点 (1)
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