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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- Total Gaviscon® tablets consumption by patients using alginate as rescue medication
研究概览
简要总结
Many patients with acid reflux disease do not improve with regular doses of proton pump inhibitors (e.g., omeprazole). The goals of this clinical trial is the to see if taking MARIAL®, in combination with omeprazole, for one month improves symptoms of acid reflux disease compared to taking omeprazole alone.
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®.
详细描述
This is an open-label, comparative, multicenter study with two parallel groups of patients. The clinical trial has the registered name GENYAL® and will be conducted at five clinical sites.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Neither the patients nor the Investigator will be blinded to the treatment to which the patients will be allocated.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: MARIAL® + PPI (generic Omeprazole) (Combination Product)
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.
干预措施: MARIAL® alone (Device)
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.
干预措施: PPI alone (generic omeprazole) (Drug)
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.
干预措施: MARIAL® alone (Device)
结局指标
主要结局
Total Gaviscon® tablets consumption by patients using alginate as rescue medication
时间窗: 28 days
The 28-day visit will assess the outcome by reviewing the patients' diary card. This diary card records their usage of Gaviscon® tablets and calculates the number of unused Gaviscon® tablets they received during baseline. The consumption of Gaviscon® tablets from baseline to the final visit in the Marial® + PPI group will be compared to that of the PPI-only group.
次要结局
- Reflux Symptoms Index (RSI)(180 days)
- GERD Impact Scale (GIS)(180 days)
- GERD Health-Related Quality of Life (GERD-HRQL)(180 days)
- Investigator Global Assessment of the Performance (IGAP)(180 days)
- Investigator Global Assessment of Safety (IGAS)(180 days)
- Serious Adverse Device Effects (SADE), Serious Adverse Events (SAE), Adverse Device Effects (ADE), Adverse Events (AE), and Device Deficiency (DD)(180 days)
- Esophagogastroduodenoscopy (EGD)(28 days)
- GERD recurrence rate(150 days)