EUCTR2006-004882-32-NL进行中（未招募）1 期
Evaluation of clinical endpoints for treatment-induced changes in GERD-related symptoms - CONQUEST
ALTANA Pharma bv0 个研究点目标入组 0 人开始时间: 2006年10月20日最近更新:
适应症
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
- 性别
- All
入选标准
- •· Written informed consent
- •· Aged at least 18 years
- •· History of GERD-related symptoms of at least 6 months prior to B0
- •· Heartburn on at least 3 days within the last 7 days prior to B0 as assessed by the investigator
- •· Acid complaints on at least 3 days within the last 7 days prior to B0 as assessed by the investigator
- •· Endoscopically confirmed GERD A - D classification determined via the Los Angeles classification system or symptom-based diagnosis of NERD
- •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
- •· Zollinger-Ellison syndrome or any other gastric hypersecretory condition
- •· previous acid-lowering surgery or any other surgery of the oesophagus and / or upper gastrointestinal tract, with the exception of polyectomy and cholecystectomy
- •· presence of obstructive oesophageal strictures, Schatzki’s ring, oesophageal diverticula, oesophageal varices, achalasia or Barrett’s oesophagus with known high-grade dysplasia or longer than 3 cm
- •· acute peptic ulcer and / or ulcer complications
- •· pyloric stenosis
- •· inflammatory bowel diseases
- •· severe or unstable cardiovascular, pulmonary and / or endocrine disease, clinically significant renal or hepatic disease or dysfunction, haematological disorder, severe psychiatric or neurological disorders or any other clinically significant condition
- •· malignancy of any kind within 5 years prior to B0, with the exception of successfully treated basal or squamous cell cancer of the skin
- •· known or suspected hypersensitivity to the study medication
- •· known or suspected alcohol or drug abuse within 1 year prior to B0
- •· clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation, as assessed by the investigator
- •· pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of reliable contraception in women of child-bearing potential
- •· any medication for the purpose of the eradication of Helicobacter pylori within the last 28 days prior to B0
- •· systemic glucocorticosteroids, NSAIDs or COX-2 inhibitors for more than 3 consecutive days within the last 28 days prior to B0, with the exception of acetylsalicylic acid not more than 150 mg per day
- •· dyspepsia-inducing drugs for more than 3 consecutive days within the last 7 days prior to B0
- •· use of any other non-allowed drug
- •· wash-out times of non-allowed drugs cannot be adhered to
- •· participation in another study within 30 days preceding visit B0 and during the present study
- •· previous enrolment into the treatment period of the current study
- •· patients who are expected to be non-compliant and or non-cooperative or who not able to follow the procedures of the study due to for instance language problems or psychological disorders
- •Concomitant medication
- •The use of the following medication is not allowed:
- •· PPIs, with the exception of the study medication, H2-receptor antagonists, prokinetics, sulcralfate, bismuth preparations or any other substance that may have an influence on the relief of acid-related symptoms, with the exception of antacids
- •· Any medication for the purpose of the eradication of H. pylori
- •· Systemic glucocorticosteroids, NSAIDs or COX-2 inhibitors for more than 3 consecutive days, with the exception of acetylsalicylic acid less than 150 mg per day
- •· Ketoconazole or any other drug with pH-dependent absorption
- •· dyspepsia-inducing drugs for more than 3 consecutive days
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