Mipolixin® Compared to Poliprotect® in Moderate Functional Dyspepsia and Heartburn.

Study Overview
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Brief Summary
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Evaluation of the clinical efficacy of two medical devices, Mipolixin® and Poliprotect®, in improving the overall symptom severity of functional dyspesia and/or heartburn

Official Title
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Efficacy and Safety of Mipolixin® Compared to Poliprotect ® in the Relief of Symptoms of Moderate Functional Dyspepsia and Heartburn: A Randomized, Double-blind, Parallel Group,Non-inferiority Clinical Study

Conditions
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Dyspepsia, Heartburn

Intervention / Treatment
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* Device: Mipolixin®
* Device: Poliprotect®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide informed consent, preferably in writing or, failing that, orally in front of a witness, before any study procedure is performed. Male and female patients aged 18 to 75 years old (inclusive). Patients with symptoms of functional dyspepsia (according to the Rome IV criteria) of moderate severity (VAS score between 30 mm and 70 mm) and/or bothersome heartburn within 2 and 14 days prior to the screening/baseline visit. o According to the current Rome IV diagnostic criteria, functional dyspepsia is defined as one or more of the following symptoms: postprandial fullness (classified as postprandial distress syndrome), early satiation (inability to finish a normal sized meal, also classified as postprandial distress syndrome), and epigastric pain or burning (classified as epigastric pain syndrome). Ability of the patients (according to the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects. Patients who agree not to alter their diet in any way for the duration of the trial and to maintain it at steady state. Patients who agree not to make any major lifestyle changes during the trial. Willingness to comply with all the study procedures and schedule. Chronic therapies (if not related to the gastroenterological pathologies object of the study, according to the opinion of the investigator) are allowed, if the regimen is maintained stable during the whole study. Exclusion Criteria: Declines or unable to provide informed consent. - Disease or health condition Patient presenting at least one of the following symptoms or conditions at screening: anemia, chronic gastrointestinal bleeding, progressive unintentional weight loss, epigastric mass, anorexia, persistent or recurrent vomiting, dysphagia or odynophagia, porphyria, hypophosphatemia, and/or cachexia. Patients presenting with at least of the following gastrointestinal conditions at screening: erosive GERD, Barrett's oesophagus or oesophageal stricture, active or healing gastroduodenal ulcer (except scars), history of gastric, duodenal or esophageal surgery, symptomatic gallstone, and/or other gastrointestinal disease such as gastroenteritis, inflammatory bowel disease, celiac disease and/or colorectal cancer. Patients with known malignancy disease, infectious disease or severe heart or pulmonary disease. Patients with known severe liver or kidney disease (AST/SGOT, ALT/SGPT >2 upper limits of normal, serum creatinine >1.5 mg/dl). Patients with mental or metabolic disorders and any other disease that according to the physician can compromise the patient´s safety and/or patient´s study compliance. - Treatments Patients receiving any treatment (pharmacological or medical device) for heartburn or dyspeptic symptoms within the last 14 days prior to randomization. Patients receiving any drugs that could affect symptoms or study evaluation such antacids, PPIs, H2RAs, prokinetics, and/or gastric mucosal protectants at baseline and/or taken within the last 14 days prior to randomization. Patients receiving any drugs that could affect symptoms or the study as antibiotics, NSAIDs, anticholinergics and/or cholinergic agents. Note: Patients will be asked to avoid any drugs of the above mentioned since the beginning of the study (baseline visit) until the end of the study. Patients under triple therapy or eradication therapy against Helicobacter pylori. Patients planned for long-term new therapies with anti-anxiety agents, glucocorticosteroids and anti-inflammatory agents during study period. Known hypersensitive or intolerance to any components of the study medical devices. Previous intake of any of the study medical devices. - Other general conditions Patients who are unable to understand or are unwilling to sign an informed consent form. Unable or unwilling to complete all required screening and/or follow-up assessments. Unable to understand and complete self-administered scales/questionnaires planned to be used in the study. Participation in interventional research studies of investigational medicinal or device products (ongoing or terminated less than 30 days before screening) Patients with active alcohol or drug addiction or any other condition that, in the investigator's opinion, would interfere with their ability to comply with the study requirements. Patients with any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol. Pregnant or nursing (lactating) women; Women of childbearing potential and sexually active: they must be willing to use at least one acceptable effective contraceptive measure (- progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action , - male or female condom with or without spermicide, - cap, diaphragm or sponge with spermicide). Pregnancy test will be performed at screening and at the final/premature withdrawal visit. The use of contraception in male patients is not required.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mipolixin®<br>Mipolixin® (Advanced Natural Antacid - AdNA) | Device: Mipolixin®<br>* 1.55g chewable tablet 5 times a day for 2 weeks<br>* Other names: Advanced Natural Antacid;|
| Active Comparator: Poliprotect®<br>Poliprotect® (Neobianacid) | Device: Poliprotect®<br>* 1.55 g chewable tablet 5 times a day for 2 weeks<br>* Other names: Neobianacid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overall symptom severity from baseline (day 0) to day 14 between the two study arms | The primary endpoint is the change in the score of a visual analog scale (VAS) (from no symptoms to overwhelming symptoms) used for evaluating overall symptom severity from baseline (day 0) to day 14 after treatment initiation, between the two study arms. A decrease in VAS score of at least 30% is considered as a clinically meaningful improvement, and therefore subjects achieving a decrease ≥30% in this scale will be considered as responders. The non-inferiority is considered demonstrated if the 95% confidence interval of the difference in the percentage of responders between both study arms lies within the non-inferior margin value defined of 20%. | Day 0 and Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responders from baseline to day 3 and day 7 | Percentage of responder patients (VAS score decrease of at least 30%) on the basis of the mean change in the overall symptom severity assessed by the VAS score from baseline to day 3 and day 7 in both study arms | Day 0, Day 3 and Day 7 | 
| Self-assessment severity of individual specific symtoms | Comparison between Mipolixin® and Poliprotect® in the mean change of the score of the self-assessed severity of individual specific symtoms (bothersome postprandial fullness, bothersome early satiation, bothersome epigastric pain, bothersome epigastric burning, and bothersome heartburn) rated on a 100 mm VAS (from no symptoms to overwhelming symptoms) from baseline to 1 3, 7 and 14 days after treatment initiation. | Day 0, Day 1, Day 3, Day 7 and Day 14 | 
| Change in the score of GOS scale from baseline to day 1 | Change in the score of GOS ( Global Overall Symptom) scale from baseline to day 14 in both study arms. A decrease in GOS score ≥2 is considered as a clinically meaningful improvement, and therefore subjects achieving a decrease in overall severity score ≥2 from baseline in this scale will be considered as responders. | Day 0 and Day 14 | 
| Incidence of AEs during study treatment | Incidence and type of adverse events (AEs) and serious adverse events (SAEs) reported during study treatment. | Day 0 to Day 14 | 
| Incidence of AEs and clinical findings during study period | Safety will be assessed on the basis of all AEs experienced during study treatment and all observed and volunteered AEs and abnormal findings on physical examination, including vital signs throughout the study. | Day 0 to Day 28 | 
| Patient satisfaction (treatment administration) | Patient level of satisfaction in terms of treatment administration/posology will be assessed by means of specific questions about patient level of satisfaction after the 2-week treatment period. The response will be scored on a 4-point Likert scale from 0 to 4, as follows: 1 = very satisfied, 2 = quite satisfied, 3 = somewhat satisfied, 4 = not satisfied. | Day 3, Day 7 and Day 14 | 
| Patient satisfaction (taste) | Patient level of satisfaction in terms of chewable tablets taste will be assessed by means of specific questions about patient level of satisfaction after the 2-week treatment period. The response will be scored on a 4-point Likert scale from 0 to 4, as follows: 1 = very satisfied, 2 = quite satisfied, 3 = somewhat satisfied, 4 = not satisfied. | Day 3, Day 7 and Day 14 | 
| Treatment compliance | Treatment compliance will be evaluated by performing the IP accountability. This data will be corroborated with the information recorded in the patient diary concerning the daily administered and missed doses. | Day 0 to Day 14 |