Study to Evaluate the Performance and Safety of the MARIAL® in Association With PPI Versus PPI Alone
NCT ID: NCT04130659
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2019-08-08
2025-01-31
Brief Summary
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Furthermore, this study will verify the effectiveness of MARIAL® as a maintenance treatment for the next five months.
This trial is called by the registered name GENYAL®.
Detailed Description
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The study population will include patients affected by gastroesophageal reflux disease (GERD) with a diagnosis of Los Angeles Classification System Grade A reflux esophagitis confirmed by gastroscopy (performed within 1 month prior to baseline) and clinical symptoms in the past 2 weeks.
Patients will be randomized to receive MARIAL® (E-Gastryal®+Magnesium Alginate) plus omeprazole versus omeprazole alone (1 month) followed by Marial® alone for an additional 5 months. The products will be administered following the respective Summary of Product Characteristics. The Investigators chosen the number of rescue medicine used (tablets of Gaviscon®) as a primary efficacy outcome to measure the performance between the two groups. The study will enroll 110 patients.
MARIAL® is a class IIa medical device that is already marketed in several EU countries. It is a combination of E-Gastryal® (hyaluronic acid, hydrolyzed keratin, tara gum, xantan gum, purified water) and magnesium alginate (MgAlg). It has been proven to actively regenerate damaged tissues through its repair and regenerative properties on the mucous membranes and its mucoadhesive and film-forming properties, which prolong the contact time with the mucous membranes and consequently improve their effectiveness.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MARIAL® and PPI; Follow-up period: MARIAL® alone
Period 1, open comparative phase: MARIAL® and PPI administered from day 1 to day 28.
Period 2, open non comparative follow up: MARIAL® alone administered from day 29 to month 6.
MARIAL® + PPI (generic Omeprazole)
MARIAL® administration: 1 stick twice daily after meals from day 1 to 28.
Omeprazole administration: 20 mg cps once daily from day 1 to day 28
MARIAL® alone
MARIAL® administration: 1 stick twice daily after meals from day 29 to month 6.
PPI alone; Follow-up period: MARIAL® alone
Period 1, open comparative phase: PPI alone administered from day 1 to day 28.
Period 2, open non comparative follow up: MARIAL® alone administered from day 29 to month 6.
PPI alone (generic omeprazole)
Omeprazole administration: 20 mg cps once daily from day 1 to day 28
MARIAL® alone
MARIAL® administration: 1 stick twice daily after meals from day 29 to month 6.
Interventions
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MARIAL® + PPI (generic Omeprazole)
MARIAL® administration: 1 stick twice daily after meals from day 1 to 28.
Omeprazole administration: 20 mg cps once daily from day 1 to day 28
PPI alone (generic omeprazole)
Omeprazole administration: 20 mg cps once daily from day 1 to day 28
MARIAL® alone
MARIAL® administration: 1 stick twice daily after meals from day 29 to month 6.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Opera CRO, a TIGERMED Group Company
OTHER
Nekkar Lab Srl
INDUSTRY
Responsible Party
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Principal Investigators
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Doina Rosu
Role: PRINCIPAL_INVESTIGATOR
Societatea Civilă Medicală Gados
Locations
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UOC Endoscopia Digestiva Chirurgica Policlinico Gemelli - Universita Cattolica
Roma, , Italy
Cabinet Particular Policlinic Algomed
Timișoara, Timiș County, Romania
Societatea Civilă Medicală Gados
Timișoara, , Romania
Medlife SA
Timișoara, , Romania
Centrul Medical Salvosan Ciobanca
Zalău, , Romania
Countries
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Central Contacts
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Facility Contacts
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Guido Costamagna, MD, Prof
Role: primary
References
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El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13.
Kung YM, Hsu WH, Wu MC, Wang JW, Liu CJ, Su YC, Kuo CH, Kuo FC, Wu DC, Wang YK. Recent Advances in the Pharmacological Management of Gastroesophageal Reflux Disease. Dig Dis Sci. 2017 Dec;62(12):3298-3316. doi: 10.1007/s10620-017-4830-5. Epub 2017 Nov 6.
Strugala V, Avis J, Jolliffe IG, Johnstone LM, Dettmar PW. The role of an alginate suspension on pepsin and bile acids - key aggressors in the gastric refluxate. Does this have implications for the treatment of gastro-oesophageal reflux disease? J Pharm Pharmacol. 2009 Aug;61(8):1021-8. doi: 10.1211/jpp/61.08.0005.
Aragona SE, Mereghetti G, Bianchetti M, Mangiavillano B, Zurlo T, Lotti J, La Mantia I, Franca K, Lotti T. Regenerative medicine in the treatment of gastro-esophageal reflux disease and laryngo-pharyngeal reflux. From research to cure. J Biol Regul Homeost Agents. 2017 APR-JUN;31(2 Suppl. 2):207-212.
DeVault K, McMahon BP, Celebi A, Costamagna G, Marchese M, Clarke JO, Hejazi RA, McCallum RW, Savarino V, Zentilin P, Savarino E, Thomson M, Souza RF, Donohoe CL, O'Farrell NJ, Reynolds JV. Defining esophageal landmarks, gastroesophageal reflux disease, and Barrett's esophagus. Ann N Y Acad Sci. 2013 Oct;1300:278-295. doi: 10.1111/nyas.12253.
Aragona SE, Mereghetti G, Ciprandi G. Gastric reflux: the therapeutical role of Marial(R). J Biol Regul Homeost Agents. 2018 Jul-Aug;32(4):969-972.
Hillman L, Yadlapati R, Thuluvath AJ, Berendsen MA, Pandolfino JE. A review of medical therapy for proton pump inhibitor nonresponsive gastroesophageal reflux disease. Dis Esophagus. 2017 Sep 1;30(9):1-15. doi: 10.1093/dote/dox055.
Reimer C, Lodrup AB, Smith G, Wilkinson J, Bytzer P. Randomised clinical trial: alginate (Gaviscon Advance) vs. placebo as add-on therapy in reflux patients with inadequate response to a once daily proton pump inhibitor. Aliment Pharmacol Ther. 2016 Apr;43(8):899-909. doi: 10.1111/apt.13567. Epub 2016 Feb 22.
Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7. doi: 10.1016/s0892-1997(02)00097-8.
Jones R, Coyne K, Wiklund I. The gastro-oesophageal reflux disease impact scale: a patient management tool for primary care. Aliment Pharmacol Ther. 2007 Jun 15;25(12):1451-9. doi: 10.1111/j.1365-2036.2007.03343.x.
Spada C, Salvi D, Pecere S, Mangiola F, Varca S, Rosu S, Prateek V, Ciobanca PV, Goldis A, Barattini DF, Costamagna G. E-Gastryal(R) + Magnesium Alginate Plus PPI vs. PPI Alone in GERD: Results from the GENYAL(R) Randomized Controlled Trial. J Clin Med. 2025 Jul 7;14(13):4794. doi: 10.3390/jcm14134794.
Other Identifiers
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2019-004062-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NEK/MD/0119
Identifier Type: -
Identifier Source: org_study_id