A prospective, comparative, controlled, randomized, open label, parallel, 3-arm study to evaluate and compare the efficacy and safety of Troxipide (100 mg) and Rabeprazole (20 mg) alone and in combination in patients suffering from acid peptic disorders - TRO/RAB/11/2011

Government Medical College Hospital0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Patients with symptoms of dyspepsia having Glasgow Dyspepsia Severity Score > 2
•Patients undergoing upper gastro intestinal endoscopy having signs of any of acid peptic disorder
•Subjects who provide a written informed consent

•History of any diagnosed gastrointestinal disorder other than acid peptic disorder
•History of any previous abdominal / gastrointestinal surgery
•History of treatment with drugs capable of interfering with digestive mucosal integrity, acid secretion or gastrointestinal motility, (including H2 receptor antagonists, NSAIDs, muscarinic antagonists, cytoprotective agents) within the previous 7 daysys
•Requires concomitant medication which precludes the evaluation of study medications
•Patients with signs suggestive of any acute complication of acid peptic disorder
•Any contraindication for endoscopy examination
•Evidence of gastric malignancy, pyloric obstruction, or oesophageal stricture on endoscopy
•Patients who are drug or alcohol abusers
•Patients with known hypersensitivity to any of the ingredients of the test / Comparator formulation
•Patients with impairment of renal or hepatic function, severe cardiac disease, any respiratory disease or haematological abnormality
•Pregnant or lactating females
•Simultaneous participation in another clinical study 30 days prior to the study

发起方