Efficacy and tolerability investigations of a healing water in symptomatic treatment of heartburn MedDRA version: 20.0 Level: LLT Classification code 10019326 Term: Heartburn System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Staatl. Fachingen STILL
Product Name: Staatl. Fachingen STILL
Product Code: 6959688.00.00
Pharmaceutical Form: Oral liquid
INN or Proposed INN: Healing water
Other descriptive name: HYDRO
Sponsors
Fachingen Heil- und Mineralbrunnen GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is: • • to demonstrate superiority of Staatl. Fachingen STILL compared to placebo with regard to the responder rate by means of change in RDQ score in the dimension heartburn ;Secondary Objective: The secondary objectives are: • characterisation of therapeutic progress by means of questionnaires (RDQ/QOLRAD) determined at each visit • characterisation of efficacy based on frequency and intensity of daily heartburn episodes • evaluation of treatment satisfaction for medication (TSQM-9) by patient at each visit under treatment • evaluation of treatment by investigator at each visit under treatment • use of rescue medication • evaluation of body weight after treatment compared to baseline • documentation and analysis of AEs (frequency and severity) ;Primary end point(s): The symptom rating score of the RDQ in the dimension of heartburn will serve for determination of the primary variable;Timepoint(s) of evaluation of this end point: after data base closure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • absolute change from baseline in dimension "heartburn", “regurgitation” and “dyspeptic complaints” of the RDQ at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5)) • absolute change from baseline in dimension "heartburn", “regurgitation” and “dyspeptic complaints” of the RDQ considering “frequency” at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5)) • absolute change from baseline in dimension "heartburn" “regurgitation” and “dyspeptic complaints” of the RDQ considering “severity” at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5)) • absolute change from baseline in the total score of the RDQ at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5)) • absolute change from baseline in the total score of the QOLRAD at each a visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5)) • absolute change from baseline in each category of the QOLRAD at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5)) • evaluation of treatment satisfaction for medication (TSQM-9) by patient at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5)) • evaluation of effectiveness and safety/tolerability of the treatment by investigator (VRS) at each visit under treatment (visit 3 and visit 4 and at end of study examination (visit 5)) • use of rescue medication • absolute change in body weight after treatment compared to baseline ;Timepoint(s) of evaluation of this end point: The secondary endpoint for evaluation of efficacy will be determined after 6 weeks of treatment. | — |
Countries
Germany
Contacts
Public ContactClinical Trial Information
Fachingen Heil- und Mineralbrunnen GmbH
Outcome results
None listed