Investigation of efficacy and tolerability of the healing water Staatl. Fachingen STILL in patients for symptomatic treatment of heartburn in comparison to placebo - Healing water efficacy in heartburn

Fachingen Heil- und Mineralbrunnen GmbH0 sites150 target enrollmentJuly 19, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Efficacy and tolerability investigations of a healing water in symptomatic treatment of heartburn
Sponsor: Fachingen Heil- und Mineralbrunnen GmbH
Enrollment: 150
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

July 19, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•At screening visit:
•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 5 years 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:

•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 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)