This double-blind, randomised, placebo-controlled trial with parallel-group design was conducted from April 2019 to June 2021 in 12 study sites in Germany in accordance with the Declaration of Helsinki (version 2013) and the requirements of the German Medicinal Products Act.
The trial was planned with an adaptive design in two stages to determine the superiority of Staatl. Fachingen Still (verum) over placebo in terms of efficacy for the treatment of heartburn. Placebo was a conventional mineral water with far lower mineralisation than verum. Verum and placebo were visually similar and packed in identical bottles with the same label. Furthermore, both study drugs had a comparable low content of carbonic acid (for composition of study drugs, seeonline supplemental methods ). After screening, the patients went through a run-in phase during which they were advised to drink at least 1.5 L/day of water or other beverages. Only patients with an intake of at least 1.5 L/day of liquids on at least 10 days prior to baseline and with a Reflux Disease Questionnaire (RDQ) score ≥8 in the dimension ‘heartburn’ considering the last 7 days prior to baseline were eligible for randomisation. Patients were centrally allocated to the lowest yet unassigned random number in a blinded fashion to either the verum or placebo group (ratio 1:1, block randomisation with block size n=4). During the treatment period, each patient received for 42 days (6 weeks) either 1.5 L/day of verum or 1.5 L/day of placebo, both to be drunk over the course of the day. The volume of intake was documented in a diary and controlled by the number of empty/full bottles returned. Rescue medication was provided within the clinical trial (Rennie Kautabletten—calcium carbonate/magnesium carbonate); intake was allowed in case the patient considered the heartburn episode as not tolerable and had to be documented. Patients were advised not to change their general eating habits during the trial. Patients, investigators and trial staff remained blinded for the entirety of the trial duration and data analysis.
The trial is registered in the EU Clinical Trials Register (EudraCT no. 2017-001100-30) and the German Registry of Clinical Studies (DRKS00016696).
The trial was planned with an adaptive design in two stages to determine the superiority of Staatl. Fachingen Still (verum) over placebo in terms of efficacy for the treatment of heartburn. Placebo was a conventional mineral water with far lower mineralisation than verum. Verum and placebo were visually similar and packed in identical bottles with the same label. Furthermore, both study drugs had a comparable low content of carbonic acid (for composition of study drugs, see
The trial is registered in the EU Clinical Trials Register (EudraCT no. 2017-001100-30) and the German Registry of Clinical Studies (DRKS00016696).
