EUCTR2006-002777-42-LT进行中（未招募）不适用
Endoscopic healing and tolerability of Soraprazan 20 mg qd compared to Soraprazan 10 mg qd and to Esomeprazole 40 mg qd in patients suffering from GERD Grade A-D (LA classification) - SPEED
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 750
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
- •· Written informed consent by the patient for study participation, prior to protocol specific procedures
- •· Outpatients being 18 - 65 years of age
- •· Endoscopically confirmed gastroesophageal reflux esophagitis (Grade A-D classification, determined via the Los Angeles classification system, including photo documentation)
- •· Frequent episodes of acid-related symptoms defined as on at least 4 days during the last week prior to inclusion into the study
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Signs, indicating other gastrointestinal diseases
- •· Zollinger-Ellison syndrome or other gastric hypersecretory condition
- •· Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy)
- •· On initial endoscopy, presence of obstructive esophageal strictures, Schatzki’s ring, esophageal diverticula, esophageal varices, achalasia or Barrett’s esophagus with known high-grade dysplasia or longer than 3 cm
- •· Symptomatic GERD without any endoscopic finding
- •· Acute peptic ulcer and/or ulcer complications
- •· Pyloric stenosis
- •· Symptoms of irritable bowel syndrome that dominate the clinical picture
- •· Inflammatory bowel diseases
- •Other concomitant diseases
- •· Myocardial infarction within the previous 3 months prior to inclusion into the study or any unstable or severe heart disease (e.g. clinically overt heart failure (NYHA III-IV), unstable angina pectoris, severe uncontrolled arterial hypertension)
- •· Subjects with percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 3 months prior to inclusion into the study
- •· History of drug-induced Torsade de Pointes, or presence of a familial long QT syndrome
- •· History or evidence of clinically relevant arrhythmias (atrial fibrillation, frequent and complex extrasystoles, ventricular tachycardia, ventricular pre-excitation syndromes)
- •· Relevant serum hypokalemia (< 3,5 mmol/L)
- •· Severe or unstable pulmonary or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
- •· Malignant disease of any kind during the previous 5 years except for successfully treated skin (basal or squamous cell) cancer
- •· Tendency to react allergically to drugs, especially with known hypersensitivity to one of the compounds of the study medication (except isolated allergy to penicillin or related antibiotics)
- •· Alcohol, drug or medication abuse within the past year
- •· Clinically relevant abnormal vital signs suggesting an underlying disease and requiring further clinical evaluation
- •· Severe psychiatric or neurologic disorders
- •Special restrictions for female patients
- •· Pregnant or nursing female patients
- •· Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as
- •- oral, injectable, or implantable contraceptives,
- •- intrauterine contraceptive devices,
- •- or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- •Please note that female patients who are surgically sterilized / hysterectomized, or post-menopausal > 2 years are not considered as being of childbearing potential.
- •Previous medication
- •· Intake of proton pump inhibitors (PPIs) during the previous 14 days prior to the start of the study
- •· H2-receptor antagonists or prokinetics during the last 7 days before the start of the study
- •· Any medication for the purpose of the eradication of H. pylori during the last 28 days before the start of the study
- •· Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (>5 days on demand but not more than 3 consecutive days) during the last 28 days before the start of the study; except regular intake of acetylsalicylic acid in dosages up to 150 mg
研究者
相似试验
进行中（未招募）
不适用
Symptom relief and tolerability of Soraprazan 20 mg qd and Soraprazan 10 mg qd compared to Esomeprazole 20 mg qd in patients with non-erosive gastroesophageal reflux disease (NERD) - SPRINTEUCTR2006-002779-42-LTALTANA Pharma AG750
已完成
不适用
Investigation of the efficacy of endoscopic scoring system for superficial non-ampullary duodenal epithelial tumorssuperficial non-ampullary duodenal epithelial tumorsJPRN-UMIN000039063TT Medical Center Tokyo40
尚未招募
不适用
Investigation of the treatment effect of Lansoprazole to sleep related GERDJPRN-UMIN000008063niversity of Juntendo, Department of Gastroenterology200
招募中
2 期
Safety and efficacy of postoperative enoxaparin treatment in patients undergoing curative hepatobiliary-pancreatic cancer surgery: a prospective, Phase Two, multi-center studyhepatobiliary-pancreatic cancerJPRN-UMIN000019368Department of Surgery, Osaka University Graduate School of Medicine260
已完成
4 期
VISIOErosive EsophagitisJPRN-jRCTs031180040Akiyama Junichi195