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

Phase 1

• Conditions: Efficacy and tolerability investigations of a healing water in symptomatic treatment of heartburn; MedDRA version: 20.0Level: LLTClassification code 10019326Term: HeartburnSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-001100-30-DE
• Lead Sponsor: Fachingen Heil- und Mineralbrunnen GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-19
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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:
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

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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 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)
6. diagnosed irritable bowel syndrome
7. patients, who rely on regular intake of medicines with pH-dependent absorption (i.e. HIV protease inhibitors, tyrosine kinase inhibitors)
8. known calcaemia (e.g. as a result of hyperparathyroidis, vitamine D overdose, paraneoplastic syndrome)
9. known nephrolithiasis due to calcium-containing kidney stones
10. known hypophosphatemia
11. known hypercalciuria
12. known hereditary problems of fructose intolerance, glucose-galactose malabsorption or saccharase isomaltase deficiency
13. patients with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
Lack of suitability for the clinical trial
14. history of surgical intervention at oesophagus or gastric and jejunal area
15. known or suspected drug or alcohol abuse within the last year
16. known or suspected eating disorders (e.g. bulimia)
17. continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs e.g. piroxicam, ketoprofen, diclofenac, acetylsalicylic acid or indomethacin (occasionally treatment with NSAIDs or except for ASS 100 mg daily is permitted, see also chapter 13.4.4.))
18. use of PPIs within 4 weeks prior to screening visit
19. participation in a clinical trial during the last 30 days prior to individual enrolment of the patient
For female patients with childbearing potential only:
20. positive pregnancy test at screening examination
21. pregnant women
22. female patients who do not agree to apply highly effective contraceptive methods
Administrative reasons
23. patients suspected or known not to follow instructions especially with regard to drinking habits and general eating habits during the study
24. patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
25. patients with close affiliation with the sponsor or the investigational site; e.g. close relative of the investigator or a dependent person (e.g. employee)
Furthermore, at baseline visit:
26. severe renal impairment (i.e. eGFR = 29 mL/min/1.73 m2 determined from serum creatinine during screening)
27. laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
28. use of PPIs within 4 weeks prior to baseline visit (during run-in period)
29. use of H2-receptor antagonists, prokinetics, healing waters or antacids other than the rescue medication within 2 weeks prior to baseline visit (during run-in period)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified