A MULTICENTRIC,RAANDOMIZED,COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF TROXIPIDE IN THE TREATMENT OF GASTRITIS AND/OR GASTRIC ULCER DISEASE

EMCURE PHARMACEUTICALS LIMITED0 个研究点目标入组 220 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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•Male or female patients between 18-65 years of age.
•Clinical signs and endoscopic diagnosis of gastric mucosal injury (erosion/ oozing/redness/edema) as in gastritis (acute or acute exacerbation of chronic gastritis) and/or benign gastric ulcer.
•Willing to give written informed consent and willing to comply with trial protocol.

•Patients with a known history of hypersensitivity to study medications
•Patients who have taken a PPI or a H2 blocker or prokinetic agent or any other gastroprotective agent within seven days of screening
•Patients who are pregnant, possibly pregnant, lactating or who desire to become pregnant during the study
•Patients who are unsuitable for pharmacotherapy with perforation or pyloric stenosis, esophageal stricture, intestinal obstruction
•Patients with history of pathological conditions of the intestine including inflammatory bowel disease, malabsorption syndromes, gastrointestinal malignancy, gastric or intestinal surgery including vagotomy, Barretts esophagus and scleroderma
•Patients with signs of significant massive GI bleeding
•Patients with poorly controlled associated disease such as: heart disease, thyroid disorders, coagulation disorders and hematologic problems etc
•Patients requiring the use of COX 2 inhibitors
•Patients with pernicious anemia or other causes of autoimmune gastritis
•Patients with severe renal disorder
•Patients with a history of severe liver disease, including cirrhosis and acute or chronic hepatitis or abnormal laboratory tests at the initial visit
•Patients who are otherwise judged inappropriate for inclusion in the study by the investigator.

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