COMPARISON OF TROXIPIDE WITH RANTIDINE IN THE TREATMENT OF GASTRITIS AND/OR GASTRIC ULCER DISEASE
- Registration Number
- CTRI/2010/091/000915
- Lead Sponsor
- EMCURE PHARMACEUTICALS LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy variable is proportion of patients showing improvement in baseline endoscopic findings.Timepoint: 28 days and 4 visits in 4 weeks
- Secondary Outcome Measures
Name Time Method ?Proportion of patients with &#8805; 50% improvement in baseline symptom severity.<br>Improvement in visual analog scale (VAS) symptom severity scores. <br>Patient?s and Physician?s global assessment at the end of study.<br>Timepoint: 28 days and 4 visits in 4 weeks