Functional dyspeptic complaints, particularly heartburn (at least 3 months prior to study start, at least twice per week) MedDRA version: 14.1 Level: LLT Classification code 10019326 Term: Heartburn System Organ Class: 100000004856
Conditions
Interventions
Trade Name: St. Gero
Pharmaceutical Form: Oral liquid
INN or Proposed INN: Heilwasser
Other descriptive name: The active principle of the IMP is the fixed combination of inorganic salts and free carbo
Sponsors
Gerolsteiner Brunnen GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: -Male and female persons between 18 and 64 years -Heartburn in at least 3 months prior to the study, at least 2 times a week (according to patient's statement) -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 or low-mineral mineral water daily (according to patient's statement) -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): -Heartburn at least 2 times a week (according to subject's diary between Visit 1 and Visit 2) -Intake of at least 1500 ± 200 ml water (incl. tea) or spring / table water daily (according to patient's diary between Visit 1 and Visit 2) 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Weight loss of = 6 kg in the last 6 months prior to the study -Gastrointestinal bleeding within 12 months prior to the study -Severe damage to the stomach wall -Difficulty swallowing (dysphagia) -Zollinger–Ellison syndrome, oesophageal or gastric malignancy, gastric or duodenal ulcer, Barrett’s oesophagus, oesophageal varices or systemic sclerosis -Coronary disease (e.g. myocardial infarction, coronary stent, angina pectoris symptoms etc.) -Anorexia -Inflammatory bowel syndrome -Previous surgery of the oesophagus, stomach or small intestine -Acute or chronic intestinal diseases (e.g. constipation, colonic stenosis etc. ) and/or acute inflammatory diseases in gastrointestinal tract -Endocrine disorders (e.g. diabetes mellitus, thyroid dysfunction) -Severe renal impairment -Urinary infections with E. coli -Susceptibility to development of calcium-containing urinary stones -Susceptibility to development of “infection stones” -Iron deficiency anemia -Persistent vomiting -Family history of gastrointestinal tract malignancy -Clinically relevant deviations of laboratory parameters -Use of antacids, H2 receptor antagonists, motility stimulants, prokinetics or other treatment for the relief of reflux within 2 days or proton-pump inhibitors or psychiatric medication within 14 days prior to study start and during the study -Use of treatment for Helicobacter pylori eradication or bismuth compounds within 3 months prior to study start and during the study -Use of acetylsalicylic acid and nonsteroidal anti-inflammatory drugs during the study -Intake of hydrogen carbonate containing beverages (>500 mg/l) within the last month prior to study start and during the study -Intake of mineral / healing water other than the investigational product 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 study start 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 committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of the efficacy and tolerability of St. Gero in the pre / post comparison. Efficacy parameters: -Therapeutic course based on the questionnaire data (questionnaires "Reflux Disease Questionnaire" (RDQ) / "Quality of Life in Reflux and Dyspepsia" (QOLRAD) / "Gastrointestinal Quality of Life Index" (GLQI)) -Difference in the frequency of heartburn episodes per week -Difference in the subjective perception of well-being (SF-12 questionnaire ) -Global assessment of efficacy by patient and investigator Tolerability parameters: -Adverse events (AEs) -Difference in blood pressure/heart rate -Differences in safety laboratory parameters -Global assessment of tolerability by patient and investigator ;Secondary Objective: As the study is designed as pilot study, there are no primary and secondary objectives defined.;Primary end point(s): Investigation of the efficacy and tolerability of St. Gero in the pre / post comparison. Efficacy parameters: -Therapeutic course based on the questionnaire data (questionnaires "Reflux Disease Questionnaire" (RDQ) / "Quality of Life in Reflux and Dyspepsia" (QOLRAD) / "Gastrointestinal Quality of Life Index" (GLQI)) -Difference in the frequency of heartburn episodes per week -Difference in the subjective perception of well-being (SF-12 questionnaire ) -Global assessment of efficacy by patient and investigator Tolerability parameters: -Adverse events (AEs) -Difference in safety laboratory parameters -Difference in blood pressure/heart rate -Global assessment of tolerability by patient and investigator;Timepoint(s) of evaluation of this end point: Efficacy: -Therapeutic course based on the questionnaire data (RDQ/QOLRAD/GLQI) at V2, V3, V4 and V5 -Frequency of heartburn episodes per week in the week before V2, V3, V4 and V5 -Subjective perception of well-being (SF-12) at V2, V3, V4 and V5 -Global assessment of efficacy by patient and investigator at V5 Tolerability: -AEs during the study -Safety laborator | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As the study is designed as pilot study, there are no primary and secondary objectives defined.;Timepoint(s) of evaluation of this end point: As the study is designed as pilot study, there are no primary and secondary objectives defined. | — |
Countries
Germany
Contacts
Public ContactLeiter Techn. Entw. u. Ressourcen
Gerolsteiner Brunnen GmbH & Co. KG
Outcome results
None listed