Efficacy and Speed of Action of a Product to Control Gastric Hydration and Gastroesophageal Reflux

Study Overview
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Brief Summary
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A Randomised, Placebo-Controlled Clinical Trial off the Efficacy and Rapidity of Action of a Product Containing Sodium Alginate, Calcium and Magnesium Salts, Hyaluronic Acid and Aloe Vera to Control Oesophageal-Gastric pH and Reduce Symptoms of Gastric Reflux and Hyperacidity.

Detailed Description
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The investigators will include 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 and don't use proton pump blockers or H2-receptor antagonists. This is a multicentre clinical trial with two-phase design: Phase I: A double-blind, randomised, placebo-controlled clinical trial to assess the efficacy and rapidity of action of the medical device to reduce clinical symptoms of gastric reflux and hyperacidity under normal conditions of use. This phase I will be performed in primary care clinics. Phase II: A non-comparative, non-controlled clinical trial to objectively assess, using continuous pH monitoring, the magnitude and rapidity to control gastric and oesophageal pH after taking the product. This phase II will be performed at the Department of Gastroenterology of Medic Center. The study will begin with the baseline visit (day 0) in which the inclusion and exclusion criteria will be confirmed, the signing of informed consent will be obtained, GERD-Q Questionnaire will be done and treatment will be prescribed, followed by a home recording where patients will record data on episodes of acidity and heartburn occuring during the follow-up week. A face-to-face visit will be at 7 days after to recollect information about total number of daytime and nighttime episodes of acidity/heartburn since the previous visit and repeat the GERD-Q Questionnaire.

Official Title
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Study Off Efficacy and Rapidity of Action of a Product With Sodium Alginate, Calcium and Magnesium Salts, Hyaluronic Acid and Aloe Vera to Control Oesophageal-Gastric Acidity (pH), Symptoms of Gastric Reflux and Hyperacidity

Conditions
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Oesophageal Reflux, Gastric Reflux, Hyperactivity; Stomach

Intervention / Treatment
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* Device: Antacid
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinical trial with CE marked medical device under normal conditions of use.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention (Antacid)<br>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. | Device: Antacid<br>* The tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely.<br>* Other names: Aquilea Antacid;|
| Placebo Comparator: Control<br>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. | Other: Control<br>* The tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of acidity/heartburn | Change in intensity of acidity/heartburn before and after taking the treatment, assessed by the patient using a visual analogue scale (VAS from 0=none to 10=maximum imaginable) | At the beginning and at the end of treatment, an average of 7±1 days in patients | 
| Time from treatment intake to resolution or maximum decrease in acidity/heartburn | Change in time from treatment intake to resolution or maximum decrease in acidity/heartburn as assessed by the patient using a 3-point Likert scale (<1 minute, 1-5 minutes, >5 minutes) | At the beginning and at the end of treatment, an average of 7±1 days in patients | 
| Time elapsed between product intake and intragastric pH > 4 | Change in minutes of the time elapsed between product intake and intragastric pH > 4 | Baseline visit | 
| Time with intragastric pH > 4 for 20 minutes before and after product intake | Total time in minutes of the time in intragastric pH > 4 for 20 minutes before and after product intake | Baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data | Sex, ethnicity and age data of patients | Baseline visit | 
| Time of tablet duration in the mouth before complete dissolution | Change in time of tablet duration in the mouth before complete dissolution, assessed using a 4-point Likert scale (< 1 minute, 1-3 minutes, 3-5 min, >5 minutes) | At the beginning and at the end of treatment, an average of 7±1 days in patients | 
| Number of daytime and nightime episodes of acidity/heartburn | Change in number of daytime and nightime episodes of acidity/heartburn (information recorded in the Patient Diary) | An average of 7±1 days in patients | 
| Intensity of reflux before and after treatment | Change in intensity of reflux before and after treatment, assessed by the patient using a visual analogue scale (VAS from 0=none to 10=maximum imaginable) | At the beginning and at the end of treatment, an average of 7±1 days in patients | 
| Gastroesophageal Reflux Disease Questionnaire (GERD-Q) score | Change in Gastroesophageal Reflux Disease Questionnaire (GERD-Q) score. Between 0 and 8 in symptoms questions the score don't mean GERD, more than 8 mean GERD or severe GERD if in impact questions the score is more than 2. | At the beginning and at the end of treatment, an average of 7±1 days in patients | 
| Number of Participants With Adverse Events | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | From the beginning to the end of treatment, an average of 7±1 days in patients | 
| Degree of physician and patient satisfaction with the efficacy, rapidity of action and tolerability of the product | Assessment of degree of physician and patient satisfaction with the efficacy, rapidity of action and tolerability of the product using 5-point Likert scales (0=very dissatisfied, 1=dissatisfied, 2=indifferent, 3=satisfied, 4=very satisfied). | Through study completion, an average of 6 months | 
| Mean intragastric pH | Change in mean intragastric pH for 20 minutes before and after product intake | Baseline visit | 
| Number of episodes of GER (intraoesophageal pH < 4) | Change in the number of episodes of GER (intraoesophageal pH < 4). Evaluation 20 minutes before and after taking the product | Baseline visit | 
| Time with oesophageal pH < 4 | Change in the time with oesophageal pH < 4. Evaluation 20 minutes before and after taking the product | Baseline visit | 
| Longest reflux episode (oesophageal pH <4) | Change in the time of longest reflux episode (oesophageal pH <4). Evaluation 20 minutes before and after taking the product | Baseline visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oesophageal Reflux, Gastric Reflux, Hyperactivity; Stomach, Sodium Alginate, Calcium, Magnesium Salts, Hyaluronic Acid, Aloe Vera, Gastroenterology