Open clinical trial (without placebo) with St. Gero for heartbur

• Conditions: Functional dyspeptic complaints, particularly heartburn (at least 3 months prior to study start, at least twice per week); MedDRA version: 14.1Level: LLTClassification code 10019326Term: HeartburnSystem Organ Class: 100000004856; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2013-001584-22-DE
• Lead Sponsor: Gerolsteiner Brunnen GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-19
• Last Update Posted: 3 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

-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

Study & Design

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