EUCTR2005-000711-10-GB进行中（未招募）1 期
Determination of the performance characteristics of ReQuestTM in Practice in the stepped down management of GORD - PRISM
ALTANA Pharma Ltd.0 个研究点目标入组 0 人开始时间: 2005年5月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
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
- •- Patients with symptoms the doctor believes to be due to GORD and which warrant in his view treatment with proton pump inhibitors
- •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 oesophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy)
- •- On initial endoscopy, presence of obstructive oesophageal strictures, Schatzki’s ring, oesophageal diverticula, oesophageal varices, achalasia or Barrett‘s oesophagus with 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, post myocardial infarction and ventricular extra systoles), pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; haematological 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
- •- Hypersensitivity to one of the compounds of the study medication
- •- Alcohol, drug or medication abuse within the past year
- •- Abnormal laboratory parameters and vital signs considered as clinically relevant by the investigator
- •- Severe psychiatric or neurological 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, H2-receptor antagonists or prokinetics during the last 14 days before intake of study medication
- •- Any medication for the purpose of the eradication of H. pylori during the last 28 days before intake of study medication
- •- 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 intake of study medication; except regular intake of acetylsalicylic acid in dosages up to 150 mg/d
- •Concomitant medication:
- •- PPIs, (except study medication), H2-receptor antagonists or prokinetics
- •- 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 150 mg/d
- •- Ketoconazole or other drugs with pH-dependent absorption
- •- PPIs in combination with antibiotics for the purpose of the eradication of H. pylori
- •- Initiation of daily psychotropic medication
- •- Patients who are expected to be non-compliant and/or not cooperative
- •- Participation in a clinical study wi
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