EUCTR2006-000926-30-AT进行中（未招募）不适用
Investigation of clinical endpoints for treatment-induced gastroesophageal reflux disease (GERD) symptom changes - COMPETITIO
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
- 660
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
- •· Patients of at least 18 years of age
- •· History of GERD-related symptoms for at least 6 months prior to inclusion into the study
- •· Heartburn (defined as a burning feeling, rising from the stomach or lower part of the chest up towards the neck) on at least 3 days during the last week prior to inclusion into the study as assessed by the investigator
- •· Acid complaints on at least 3 days during the last week prior to inclusion into the study as assessed by the investigator
- •· Endoscopically confirmed gastroesophageal reflux esophagitis (Grade A to D classification determined via the Los Angeles classification system) or symptom-based diagnosis of endoscopic-negative GERD (enGERD)
- •· Patients whose compliance is expected to be high with respect to the completion of ReQuest™ and GERDyzer™ according to the assessment of the investigator
- •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) yes
- •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
- •· 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:
- •· Severe or unstable cardiovascular (e.g., severe angina pectoris, postmyocardial infarction and ventricular extrasystoles), 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 investigational medicinal product
- •· Alcohol, drug or medication abuse within the past year
- •· Clinically relevant abnormal laboratory values and vital signs suggesting an underlying disease and requiring further clinical evaluation (as assessed by the investigator)
- •· 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, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized, or post-menopausal > 2 years, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
- •Previous medication:
- •· PPIs during the last 7 days before the start of the study
- •· H2-receptor antagonists or prokinetics during the last 2 days before the start of the study
- •· Sucralfate, antacids, bismuth preparations or other substances, which may have an influence on the relief of acid-related symptoms during the last 2 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 163 mg/d
- •· Dyspepsia-inducing drugs, e.g., bisphosphonates, misoprostol, for more than 3 consecutive days during the last 7 days before the start of the study
- •Concomitant medication:
- •· PPIs (except investigational medicinal product), H2-receptor antagonists, prokinetics, sucralfate, antacids, bismuth preparations or other substances, which may have an influence on the relief of acid-related symptoms
- •· Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) except regular intake of acetylsalicylic acid
研究者
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