A double blind, single centric, randomized, placebo-controlled study to demonstrate the efficacy and safety of RefluG (Test product) with Placebo in the management of symptoms of Gastroesophageal reflux disease (GERD).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Giellepi Spa
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To demonstrate that Investigational product is superior to placebo and is efficacious in symptom remission (30% more symptom remission compared to placebo) in management of GERD.
研究概览
简要总结
This clinical study was planned to evaluate the safety and efficacy of a novel therapy in subjects diagnosed with Gatroesophageal reflux disease (GERD).
In this study 60 subjects will recruited who are with GERD for a treatment period of 14 days. The treatment will demonstrate that the investigational product is superior to placebo and is efficacious in symptom remission.
The treatment will also evaluate for change in symptom frequency and intensity using reflux disease questionnaire, change in GERD symptoms accessed by VAS, change in QOL using HRQL-SF36, Change in frequency scale for symptom questionnaire and change in heartburn severity index from baseline to Day 7 ans 14 and also in between the groups in these visits. This study will also evaluate number of subjects with 50% reduction of symptoms compare to baseline and number of days required to achieve 24 hours without heartburn.
The objective of the study is to evaluate the efficacy and safety of Reflux (IP) in subjects diagnosed with GERD when compared to placebo.
Type of the study - Randomized, double blind, placebo controlled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patient should be able to give written informed consent.
- •2 Diagnosis of GERD by endoscopy 3 Males and females 18 -65 years of age (both inclusive).
 4 Subjects who should be able to follow controlled diet (coffee and tea must be limited to not more than 2 cups per day, Chocolate, alcoholic beverages and spices should be reduced as much as possible).
- •5Subjects who are negative for Helicobacter pylori infection 6 Childbearing women using either oral or local contraceptives.
- •7 Ability to comply with requirements of trial.
排除标准
- •Subjects with esophagitis and complications of gastroesophageal reflux disease including oesophageal stricture, Barrett’s oesophagus or adenocarcinoma of the oesophagus Subjects with any significant intestinal maladies (including known gastric and duodenal ulcer, hiatal hernia, infections or inflammatory conditions of the small or large intestine, and obstructions) Subjects with dyspepsia, Malabsorption, celiac disease, prior gastric surgery, pyloric stenosis, or a history of erosive esophagitis or GERD refractory to 2 months of therapy with either an H2-receptor antagonist (H2RA) or a PPI.
- •Known history of drug or alcohol abuse Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
- •Subjects with clinically significant history of co-morbid condition (like, diabetes, immunodeficiency, HIV, HPV), cardiac disease, kidney disease, that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
- •Patients suffering from any condition which in opinion of the Investigator may interfere with nutrient absorption, distribution, metabolism and excretion e.g. sub-acute obstruction, celiac disease, Crohn’s disease, Small intestine bacterial overgrowth (SIBO), chronic pancreatitis, or cystic fibrosis, lactase deficiency, or lactose intolerance, biliary atresia, parasitic diseases, diseases of the gallbladder, liver, kidney or pancreas etc.
- •Subject with deteriorating health status at the time of enrolment, rapid weight loss, terminal disease, significant chronic disease (e.g, chronic diarrhoea, gastro-intestinal diseases, irritable bowel syndrome) 9.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≥ 2.5 X Upper Limit of Normal (ULN), Serum creatinine of ≥ 1.5 mg/dL 10.Subjects on Hormone replacement therapy or chemotherapy or radiotherapy.
- •Subjects participating in any other studies or participated in any clinical trial 3 months prior to start of this trial.
- •Pregnant women.
- •Known hypersensitivity to, or intolerance of, study medications or their formulation excipients.
结局指标
主要结局
To demonstrate that Investigational product is superior to placebo and is efficacious in symptom remission (30% more symptom remission compared to placebo) in management of GERD.
时间窗: Screening day, Day 0, 7 and 14
次要结局
- 1Safety will be assessed throughout by AE reporting, laboratory testing, PE, and vital signs.(2Change in symptom frequency and intensity using RDQ)