Evaluating MARIAL® with Omeprazole for Acid Reflux

Open, Comparative Study To Evaluate The Performance And Safety Of The Medical Device Marial® In Association With Proton-Pump Inhibitors Versus PPI Alone In Patients Affected By Gastroesophageal Reflux Disease

This study is testing if using the medical device MARIAL® with the heartburn medication omeprazole can help people with acid reflux feel better compared to just taking omeprazole alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Nekkar Lab Srl (Industry-sponsored)
• Locations: 5 sites (Roma and 4 other locations)
• Trial ID: NCT04130659 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the medical device MARIAL® when used in combination with the proton pump inhibitor (PPI) omeprazole for treating gastroesophageal reflux disease (GERD). Patients diagnosed with Grade A reflux esophagitis will be randomized to receive either MARIAL® plus omeprazole or omeprazole alone for one month, followed by MARIAL® alone for an additional five months. The study will measure the primary efficacy outcome based on the use of rescue medication, Gaviscon®, to compare symptom relief between the two groups. Conducted at multiple clinical sites, the trial will enroll 110 participants.

Who should consider this trial

Good fit: Ideal candidates are males or non-pregnant females aged 18 to 65 with a diagnosis of GERD Grade A esophagitis and experiencing frequent heartburn or acid regurgitation.

Not a fit: Patients who have recently taken PPIs or MARIAL® or those with certain contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with GERD who do not respond adequately to standard PPI therapy.

How similar studies have performed: While the use of PPIs is common, the combination with MARIAL® is a novel approach that has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Male or non-pregnant female, both aged ≥ 18 to ≤ 65 years.
* Diagnosis of GERD Grade A esophagitis on Los Angeles Classification System grades reflux esophagitis by:

  * gastroscopy (done within 1-month prior baseline).
  * episodic heartburn and/or acid regurgitation (at least 3 times per week in the last 2 weeks);
* Body mass index of ≥ 18.5 to ≤ 36 kg/m2.
* Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
* Capable of and freely willing to provide written informed consent prior to participating in the study.

Exclusion Criteria:

* Intake of PPI or Marial® during the last 28 days before the start of the study.
* Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (≥ 3 consecutive days per week) during the last 28 days before the start of the study; except regular intake of enteric coated aspirin dosages up to 150 mg/d.
* Previously underwent acid-lowering surgery or other surgery of the oesophagus and/or upper gastrointestinal tract (excluding appendectomy, cholecystectomy and polypectomy).
* History of co-existing disease that affects the esophagus (e.g. Barrett's esophagus, Zollinger-Ellison syndrome, esophageal stricture).
* History of active gastric or duodenal ulcers within 3 months of the first dose of the study drug or had acute upper gastrointestinal (GI) bleeding within last 6 months.
* Documented presence of severe renal or hepatic insufficiency (i.e. GOT, GPT elevated over double the normal range).
* Known hypersensitivity to omeprazole, and/or Marial® and/or Gaviscon®.
* Concurrent (or within 30 days of study entry) participation in a clinical trial.
* Females who are pregnant, or planning a pregnancy, or lactating. Females of child bearing potential not using reliable methods of birth control.
* Clinically significant laboratory abnormality or disease which, in the opinion of the Investigator, will create a risk for the patient, or interfere with study results (i.e. GOT, GPT elevated over double the normal range).
* Receiving any of the following drugs within 2 weeks before the baseline: theophylline, bismuth salts, warfarin, phenytoin, tacrolimus, diazepam, cyclosporine, disulfiram, barbiturates, antineoplastic agents, erythromycin, clarithromycin, sucralfate, clopidogrel or protease inhibitors. Benzodiazepines could be allowed only in concomitance with the endoscopy.
* Taking concomitant medications that rely on the presence of gastric acid for optimal bioavailability (e.g. ketoconazole, ampicillin esters or iron salts).
* Drug or alcohol abuse within 12 months of Day 0
* Malignancy (also leukemic infiltrates) within 5 years prior to Day 0 (except for treated basal cell/squamous cell carcinoma of the skin).
* Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety).
* Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study for its safety

Where this trial is running

Roma and 4 other locations

• UOC Endoscopia Digestiva Chirurgica Policlinico Gemelli - Universita Cattolica — Roma, Italy (Recruiting)
• Cabinet Particular Policlinic Algomed — Timișoara, Timis, Romania (Completed)
• Societatea Civilă Medicală Gados — Timişoara, Romania (Completed)
• Medlife SA — Timişoara, Romania (Completed)
• Centrul Medical Salvosan Ciobanca — Zalău, Romania (Completed)

Study contacts

• Principal investigator: Doina Rosu — Societatea Civilă Medicală Gados
• Study coordinator: Barattini Dionisio Franco

Conditions Gastroesophageal Reflux Disease; Medical Device; Proton-pump inhibitor; Magnesium Alginate; Mucosal protective agent