Efficacy and Speed of Action of a Product to Control Gastric Hydration and Gastroesophageal Reflux (AQUAA)
Oesophageal Reflux, Gastric Reflux, Hyperactivity; Stomach
About this trial
This is an interventional treatment trial for Oesophageal Reflux focused on measuring Oesophageal Reflux, Gastric Reflux, Hyperactivity; Stomach, Sodium Alginate, Calcium, Magnesium Salts, Hyaluronic Acid, Aloe Vera, Gastroenterology
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes over 18 years of age
- Patients with gastroesophageal reflux disease and heartburn (more than 3 weekly episodes of heartburn for at least 4 consecutive weeks) not related to medication intake
- Patients not on proton pump blockers or H2-receptor antagonists
- Patients able to understand the study implications and who sign the informed consent.
Exclusion Criteria:
- Pregnant or nursing women
- Patients who are currently using or have used other medications or antacid products for the treatment of reflux and hyperacidity symptoms within 7 days prior to enrolment in this study.
- Patients treated with antihypertensive drugs, calcium channel blockers or non-steroidal anti-inflammatory drugs (NSAIDs)
- Patients with hypercalcaemia, hypertension, renal failure or other conditions in which the use of the components of the investigational product is not recommended.
- Patients with serious diseases that, in the physician's opinion, could interfere with the results of the study or prevent their participation in it.
Sites / Locations
- Oriol ArmengolRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Intervention (Antacid)
Control
An Antacid, a CE marked medical device under normal conditions of use. Sodium alginate (reduces reflux) (250 mg/tablet) Calcium carbonate (reduces acidity) (80 mg/tablet) Magnesium carbonate (reduces acidity) (144 mg/tablet) Hyaluronic acid (mucosal protector) (6.15 mg/tablet) Aloe vera extract without anthraquinones (mucosal protector) (40 mg/tablet) Patients should take 2 tablets of treatment at the time they develop reflux or hyperacidity. The maximum dose will be 6 tablets per day.
The control will consist of a placebo based on excipients without active ingredients that will be formulated so that the tablet has the same appearance as the test product, with three different colour layers. Patients should take 2 tablets of treatment at the time they develop reflux or hyperacidity. The maximum dose will be 6 tablets per day.