a study to assess effectiveness amd safety of combination of two medicine will be used for treatment of gastroesophageal reflux disease.
- Conditions
- Health Condition 1: null- With Gastroesophageal reflux disease
- Registration Number
- CTRI/2012/02/002406
- Lead Sponsor
- Torrent Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
?Newly diagnosed GERD patients having non-erosive or erosive GERD with heartburn and acid regurgitation as the predominant symptoms and episode of heart burn and acid regurgitation occurring on at least 2 days during the last 7 days prior to inclusion.
?Adult males or females, age 18 years.
?All subjects who are willing to give informed consent.
?All subjects who are willing adhere to protocol requirements.
?History or presence of upper gastrointestinal anatomic or motor disorders.
?Acute peptic ulcer and/or ulcer complications.
?Bleeding disorder or History of hematemesis within last 2 months.
?Barret?s esophagus or dysplastic changes in esophagus
?Intake of Glucocortocoids or NSAIDS for more than three consecutive day/week during last month.
?Intake of PPI, H2 blocker or prokinetic for more than 3 consecutive days in previous 7 days.
?History of atrophic gastritis or gastric malignancy or other GI malignancy.
?Any major cardiovascular, pulmonary, hematologic, hepatic, renal, metabolic, gastrointestinal or endocrine disorder.
?Any major surgery in previous 1 month.
?History of Pheochromocytoma, epilepsy, mania, breast diseases
?History of drug or medication abuse within the past year, or current alcohol abuse.
?Previous participation in any esomeprazole magnesium or levosulpiride clinical trial within last 1 month.
?Hypersensitivity to PPI or levosulpiride
?Subjects with serum ALT, AST, of 2.5 X ULN and S.Bilirubin 1.5 X ULN
?Subject with serum creatinine ULN
?Women with positive urine pregnancy test.
?Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Change in the severity of GERD symptoms at the end of 3rd and 6th week of treatment. <br/ ><br>2) Change in the frequency of GERD symptoms at the end of 3rd and 6th week of treatment. <br/ ><br>Timepoint: 1) Change in the severity of GERD symptoms at the end of 3rd and 6th week of treatment. <br/ ><br>2) Change in the frequency of GERD symptoms at the end of 3rd and 6th week of treatment. <br/ ><br>
- Secondary Outcome Measures
Name Time Method ) Change in the endoscopic finding (Grade A, B, C, D) according to Los Angeles classification in patient with Erosive GERD at the end of 6 weeks of treatment.Timepoint: At the end of 6 week