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

NCT03531372 | Completed

• 1 other identifier: ABO-NB-SEM-17
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Dyspepsia; Heartburn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Responders from baseline to day 3 and day 7

  Day 0, Day 3 and Day 7

• Self-assessment severity of individual specific symtoms

  Day 0, Day 1, Day 3, Day 7 and Day 14

• Change in the score of GOS scale from baseline to day 1

  Day 0 and Day 14

• Incidence of AEs during study treatment

  Day 0 to Day 14

• Incidence of AEs and clinical findings during study period

  Day 0 to Day 28

Study Arms (2)

Mipolixin®

EXPERIMENTAL

Mipolixin® (Advanced Natural Antacid - AdNA)

Device: Mipolixin®

Poliprotect®

ACTIVE COMPARATOR

Poliprotect® (Neobianacid)

Device: Poliprotect®

Interventions

Mipolixin® DEVICE

1.55g chewable tablet 5 times a day for 2 weeks

Also known as: Advanced Natural Antacid

Mipolixin®

Poliprotect® DEVICE

1.55 g chewable tablet 5 times a day for 2 weeks

Also known as: Neobianacid

Poliprotect®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aboca Spa Societa' Agricola: lead
• La Sociedad Española de Médicos de Atención Primaria: collaborator
• Dynamic: collaborator

Study Sites (11)

CS Albuñol

Albuñol, 18700, Spain

Location

CS Disset de Setembre

el Prat de Llobregat, 08820, Spain

Location

CS Montesa

Madrid, 28006, Spain

Location

CS Goya

Madrid, 28009, Spain

Location

Primary Care Centre Eloy Gonzalo

Madrid, 28010, Spain

Location

CS Comillas

Madrid, 28019, Spain

Location

CS Baviera

Madrid, 28028, Spain

Location

CS Las Americas

Parla, 28981, Spain

Location

CS San Blas

Parla, 28981, Spain

Location

CS Isabel II

Parla, 28982, Spain

Location

Consultorio Local Perales de Tajuña

Perales de Tajuña, 28540, Spain

Location

MeSH Terms

Conditions

Dyspepsia; Heartburn

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 21, 2018
• Study Start: April 24, 2018
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

ES (11)