EUCTR2006-002779-42-LT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) - SPRINT
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 NERD (non-erosive gastroesophageal reflux disease)
- •- History of frequent episodes of GERD-related symptoms during the last 3 months prior to inclusion into the study
- •- 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)
- •- Endoscopically confirmed gastroesophageal reflux esophagitis (LA Grade A-D)
- •- 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
- •- 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
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