None listed
Conditions
Interventions
Intervention1: TROXIPIDE: 100MG,28 DAYS
Control Intervention1: RANITIDINE: 150MG,28 DAYS
Sponsors
EMCURE PHARMACEUTICALS LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is proportion of patients showing improvement in baseline endoscopic findings.Timepoint: 28 days and 4 visits in 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Proportion of patients with ≥ 50% improvement in baseline symptom severity. Improvement in visual analog scale (VAS) symptom severity scores. Patient?s and Physician?s global assessment at the end of study. Timepoint: 28 days and 4 visits in 4 weeks | — |
Countries
India
Contacts
Public ContactDr Dewan
CRA
Outcome results
None listed