EUCTR2016-000994-19-DE进行中（未招募）1 期
Doubleblind, randomised, placebo-controlled clinical trial to evaluate the safety and efficacy of Gerolsteiner Heilwasser in NERD patients with heartburn
Gerolsteiner Brunnen GmbH & Co. KG0 个研究点目标入组 80 人开始时间: 2016年4月28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
- 入组人数
- 80
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
- •- Male and female persons with NERD between 18 and 64 years
- •- Endoscopic exclusion of an erosive disease (reflux esophagitis) according to the Los Angeles Classification =1 year before visit 1 (alternatively: endoscopy at visit 1)
- •- Heartburn requisite in at least 3 months prior to the study at =4 days a week (patient’s statement)
- •- Score of the Reflux Disease Questionnaire (RDQ) for dimension heartburn and/or regurgitation =9 (the lower score must be =4)
- •- Not receiving prescribed treatment for heartburn, reflux or upper gastrointestinal disorders
- •- Subject is used to consuming at least 1.5 l of water (incl. tea) or spring water, table water, mineral water or soft drinks (patient’s statement)
- •- Commitment to consume the carbonated investigational product
- •- Commitment to adhere to former diet
- •- Commitment to only use the investigational product personally
- •- Women of childbearing potential: commitment to use contraception methods
- •Written informed consent is a prerequisite for patient enrollment.
- •Criteria for study continuation (at visit 2):
- •- Average intake of at least 1.5 l water (incl. tea) or spring water, table water or mineral water daily over a period of 7 days, starting with the first entry
- •- Heartburn at =4 days over a period of 7 days, starting with the first entry
- •- Score of the Reflux Disease Questionnaire (RDQ) for dimension heartburn and/or regurgitation =9 (the lower score should be =4), in the first week starting with the first entry of heartburn episodes in the daily patient diary
- •additionally
- •- No evidence of fecal occult blood or complete coloscopy performed within the last 5 years without evidence of neoplasia
- •as well as all applicable inclusion and no exclusion criteria are complied.
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Gastroesophageal reflux disease (GERD)
- •- Reflux disorder since >12 months prior to visit 1
- •- Batch-wise progress of the symptomatology with longer symptom free intervals
- •- Gastrointestinal bleeding within 12 months prior to visit 1
- •- Severe damage to stomach wall
- •- Difficulty swallowing (dysphagia)
- •- Odynophagia
- •- Persistent vomiting
- •- Incontinence
- •- Family history of gastrointestinal tract malignancy
- •- Zollinger-Ellison syndrome, oesophageal or gastric malignancy, gastric or duodenal ulcer, Barrett’s oesophagus, oesophageal varices systemic sceloris or gastrointestinal strictures
- •- Previous surgery of the oesophagus, the stomach or small intestine (anamnestic statement)
- •- Not-intended weight loss =6 kg in the last 6 months prior to visit 1
- •- Anorexia
- •- Acute or chronic intestinal disease (e.g. constipation, colonic stenosis, etc.) and / or acute inflammatory disease in gastrointestinal tract
- •- Irritable bowel syndrome (according to Rome-III-Criteria)
- •- Symptomatic coronary disease (e.g. myocardial infarction, angina pectoris, severe cardiac insufficiency, coronary stent, etc.)
- •- Insufficiently treated endocrine disorders (e.g. diabetes mellitus, thyroid dysfunction)
- •- Severe renal impairment
- •- Urinary infections with no alkaline treatment advisable (e.g. with E. coli)
- •- Susceptibility to development of calcium-containing urinary stones or infection stones”
- •- Iron deficiency anemia
- •- Clinically relevant deviations of laboratory parameters
- •- Use of antacids, H2 receptor antagonists, motility stimulants (prokinetics) or other treatment for the relief of gastroesophageal reflux and/or heartburn within 2 days prior to visit 1 and during the study (with exception of the provided emergency mediacation)
- •- Use of proton-pump inhibitors (PPI) within 14 days prior to visit 1 and during the study
- •- Start with or change of treatment with psychiatric medication within the last 14 days prior to visit 1 or during the study
- •- Use of treatment for Helicobacter pylori eradication (incl. bismuth compounds) within 3 months prior to visit 1 and during the study
- •- Use of acetylsalicyclic acid (ASS), nonsteroidal anti-inflammatory drugs and other drugs that can induce heartburn during the study (with exception of ASS 100 mg daily)
- •- Excessive intake of vitamin D
- •- Intake of hydrogen carbonate containing beverages (>500 mg daily) within the last month prior to visit 1 and during the study
- •- Intake of healing / mineral water or carbonated beverages during the study
- •- Pregnancy or nursing (women of childbearing potential)
- •- Drug, alcohol or medication abuse
- •- Participation in another clinical trial during the last 30 days prior to visit 1 and during the study
- •- Persons that are in relationship or dependence to the sponsor or the investigator
- •- Evidence that the subject would not be able to comply with clinical trial requirements (e.g. limited willingness to cooperate)
研究者
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