Evaluation of safety and efficacy of fixed dose combination of Pantoprazole and sustained release Levosulpiride for short term therapy of Gastroesophageal reflux disease (GERD) in patients who do not respond to PPI alone: an open label, multicentric study. - NA

Sun Pharma Laboratories Limited0 个研究点目标入组 509 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patients must meet all of the following criteria to be considered for enrollment in the study
•1.Male or female patients aged between 18 to 65 years.
•2.Patients with known history of Gastro esophageal reflux disease (GERD) within last 03 months.
•3.Patients who are on Proton pump inhibitor (PPI) alone since 4 weeks prior to screening and not adequately controlled.
•Minimum dose/day: Pantoprazole (40 mg), Esomeprazole (20 mg), Omeprazole (20 mg). Rabeprazole (20mg) and Lansoprazole (15 mg).
•3. Patients willing to give informed consent.

•Patients meeting any of the following criteria must be excluded from enrollment in the study:
•1.Pregnant lactating women or women of childbearing age who are not using an acceptable method of birth control.
•2.Patients with peptic ulcer or Zollinger Ellison syndrome.
•3.Patients with previous surgery of gastrointestinal tract excluding appendectomy, cholecystectomy and polypectomy.
•4.Patients with other diseases or conditions such as scleroderma, pancreatitis, cancer, Parkinsonâ??s disease, epilepsy, mania and inflammatory bowel disease.
•5.Patients with any severe illnesses (hepatic, renal, cardiac).
•6.Patients with uncontrolled diabetes, hypertension, clotting disorder.
•7.Heavy smokers (more than 10 cigarettes per day in last 06 months).
•8.History of hypersensitivity or known contraindication to either Pantoprazole or Levosulpiride.
•9.Recent (in the past two years) drug dependence or abuse.
•10.History of non-compliance to medical regimens or those patients unwilling to comply with the study protocol.

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