A randomized, multi-centric, active controlled, parallel group, open-label, comparative study to evaluate the efficacy and safety of Rabeprazole and Omeprazole in patients of gastroesophageal reflux disease (GERD)
- Conditions
- Digestive System
- Registration Number
- PACTR202305577953836
- Lead Sponsor
- SUN PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 486
•Subjects of either gender aged 18 to 65 years
•History of gastroesophageal reflux disease (GERD) symptoms (Heartburn ± Regurgitation) for at least 1 month immediately before screening
•Heartburn for at least 3 days a week for at least 2 weeks preceding the screening
•Willing to provide written informed consent
•Women of reproductive age group willing to use an acceptable method of contraception during the conduct of the study
•Active gastric or duodenal ulcer;
•Known case of Zollinger Ellison syndrome or Gastrointestinal malignancy
•History of oesophageal or gastric surgery or primary oesophageal motility disorder
•Active treatment or history of treatment in last 1 month with proton pump inhibitors, H2 blockers or prokinetic drugs
•Pregnancy or breast-feeding
•Impaired hepatic or renal function; uncontrolled diabetes mellitus or hypertension
•Anticoagulation therapy or clotting disorders
•Alcoholism or drug abuse
•Severe concomitant cardiovascular, hepatic, renal, pulmonary, malignant or haematological disease
•Subjects deemed inappropriate by investigator
•Patient with alarm features” in symptomatology, including odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool, pointing to a possible malignant disease of the GI tract.
•Surgical or medical condition that, in the judgement of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the study drugs.
•Patient with history of human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV).
•Participation in another clinical trial in the past 3 months or planning to participate in another clinical trial during the study
•Patients having hypersensitivity or any other contraindication to any of the Investigational products or its component.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method