A clinical study to understand the effectiveness of a new product in adult subjects with stomach problem.

Completed

Conditions: Gastro-esophageal reflux disease without esophagitis,

Registration Number: CTRI/2020/03/023910

Lead Sponsor: Giellepi Spa

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

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).â€¨ 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.

Exclusion Criteria

Subjects with esophagitis and complications of gastroesophageal reflux disease including oesophageal stricture, Barrettâ€™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, Crohnâ€™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 â‰¥ 2.5 X Upper Limit of Normal (ULN), Serum creatinine of â‰¥ 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Screening day, Day 0, 7 and 14

Secondary Outcome Measures

Name	Time	Method
1Safety will be assessed throughout by AE reporting, laboratory testing, PE, and vital signs.	2Change in symptom frequency and intensity using RDQ

Trial Locations

Locations (1): Rajalakshmi Hospital
🇮🇳
Bangalore, KARNATAKA, India
Rajalakshmi Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Pendalimari Ramesh
Principal investigator
9553252525
drrajeshrlh@gmail.com