DRKS00016696
Recruiting
Phase 3
Investigation of efficacy and tolerability of the healing water Staatl. Fachingen STILL in patients for symptomatic treatment of heartburn in comparison to placebo
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- MedDRA - Heartburn 10019326
- Sponsor
- Fachingen Heil- und Mineralbrunnen GmbH
- Enrollment
- 150
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.history of repeatedly occurring episodes of heartburn with first manifestation at least 6 months ago
- •2\.repeatedly occurring episodes of heartburn on at least 2 days per week within each of the last 4 weeks prior to screening visit
- •3\.RDQ score of \= 8 in the dimension heartburn considering the last 7 days prior to screening visit
- •4\.availability of results of a gastric endoscopy within 12 months before screening visit excluding relevant erosive disease (reflux esophagitis), i.e. assessment according to Los Angeles Classification not higher than grade A, and other severe gastrointestinal diseases including malignancies, ulcer, Barett's oesophagus, and oesophageal varices
- •5\.age: 18 years or older
- •6\.willing and able to ingest at least 1\.5 L water per day during the course of the trial
- •7\.willing not to change general eating habits for the duration of the trial, i.e. no special diet planned
- •8\.written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the patients participating in the clinical trial Furthermore, at baseline visit:
- •9\.RDQ score of \= 8 in the dimension heartburn considering the last 7 days prior to baseline visit
- •10\.intake of at least 1\.5 L water or other beverages per day on at least 10 days over the last 14 days prior to baseline visit
Exclusion Criteria
- •Safety concerns
- •1\.symptoms occurring after the time of gastric endoscopic examination:
- •a)difficulty in swallowing (dysphagia) or painful swallowing (odynophagia)
- •b)non\-intended weight loss \= 5 % of body weight
- •c)iron deficiency anaemia
- •d)experiencing episodes of persistent vomiting (at least 7 to 10 days of protracted vomiting) without causal explanation like GI virus infection
- •2\.signs of moderate or severe renal impairment known from medical history or reported during screening examination
- •3\.severe heart failure (i.e. NYHA III/IV)
- •4\.known Zollinger Ellison syndrome
- •5\.active or known inflammatory bowel diseases (e.g. colitis ulcerosa, Crohn´s disease) or other severe chronic intestinal disease (e.g. colonic stenosis)
Outcomes
Primary Outcomes
Not specified
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