Study to Evaluate the Performance and Safety of the MARIAL® in Association With PPI Versus PPI Alone

Launched by NEKKAR LAB SRL · Oct 15, 2019

Keywords

ClinConnect Summary

This clinical trial, called GENYAL®, is looking at whether adding a medication called MARIAL® to the standard treatment for gastroesophageal reflux disease (GERD) can help improve symptoms more than the standard treatment alone. Proton pump inhibitors (PPIs), like omeprazole, are commonly used to reduce stomach acid, but some patients still experience discomfort. In this study, participants will take MARIAL® along with omeprazole for one month, and then researchers will check how well their symptoms improved. Additionally, the trial will assess if MARIAL® can be a helpful treatment for the following five months.

To join the study, participants need to be adults aged 18 to 65 who have been diagnosed with mild GERD and have symptoms like heartburn at least three times a week. They should be generally healthy and able to follow the study's requirements. However, there are some important exclusions, such as having taken certain medications recently or having specific health conditions that could interfere with the study. If eligible, participants can expect to receive close monitoring throughout the trial to ensure their safety and to track their symptom changes.

Gender

ALL

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