EUCTR2005-003485-42-DE进行中（未招募）不适用
Treatment response in patients with symptoms due to gastroesophageal reflux disease either with or without esophagitis treated with pantoprazole sodium 40 mg o.d. over 8 weeks - REAL LIFE
ycomed GmbH0 个研究点目标入组 2,000 人开始时间: 2006年3月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
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 of at least 18 years of age (21 years in Argentina)
- •- Patient considered by the investigator to have symptoms due to gastroesophageal reflux disease
- •- Patients whose compliance is expected to be high with respect to the completion of the questionnaires and diaries (ReQuest™, GERDyzer™, HADS, TSS) 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
- •- 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 study medication
- •- 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
- •- 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 who are not using any other method considered sufficiently reliable by the investigator in individual cases
- •Previous medication:
- •- PPIs during the last 10 days before 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 163 mg/d
- •Concomitant medication:
- •- PPIs (except study medication), H2-receptor antagonists, prokinetics, sucralfate, misoprostol, 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 in dosages up to 163 mg/d
- •- Ketoconazole or other drugs with pH-dependent absorption
- •- PPIs in combination with antibiotics for the purpose of the eradication of H. pylori
- •- Onset or change of psychotropic medication
- •- Patients who are expected to be non-compliant and/or not co-operative
- •- Participation in a clinical study within the last 30 days prior to the start of the study
- •- Patients who have participated already in this study
- •- Patients who are employees at the investigational site, relativ
研究者
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