A clinical trial to demonstrate the safety and efficacy of a healing water (Gerolsteiner Heilwasser) on heartburn compared to placebo
- Conditions
- functional dyspeptic complaints, particularly heartburn (at least 3 months prior to study start, on at least 4 days per week)MedDRA version: 19.0 Level: LLT Classification code 10019326 Term: Heartburn System Organ Class: 100000004856Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2016-000994-19-DE
- Lead Sponsor
- Gerolsteiner Brunnen GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
- 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
- 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)
- Persons
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method