Health Condition 1: K297- Gastritis, unspecified Health Condition 2: K27- Peptic ulcer, site unspecified
Conditions
Interventions
Intervention1: Lafutidine: One Lafutidine (10 mg) tablet to be taken once daily orally for 28 days in case of gastritis and One Lafutidine (10 mg) tablet to be taken twice daily orally for 28 days in
Sponsors
Zuventus Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 years or older. 2. Clinical signs and symptoms of Acid peptic disease with endoscopic diagnosis of gastric mucosal injury (erosion/ oozing/redness/edema) as in gastritis (acute or acute exacerbation of chronic gastritis) and/or peptic ulcers (Patients with endoscopically diagnosed A1- or A2-stage ulcer (by Sakita/Miwa classification). 3. Patients willing to give written informed consent and willing to comply with trial protocol. 4. Patients who are on therapy with PPI, H2RAs, NSAIDs, muscarinic antagonists or other gastroprotective agents, but who have undergone a washout period of 7 days wherein only oral antacids are taken.
Exclusion criteria
Exclusion criteria: 1. Patients with a known history of hypersensitivity to study medications (rash, fever, itching, etc). 2. Patients who had been treated with drugs capable of interfering with digestive mucosal integrity, gastric secretion or gastrointestinal motility, including H2 receptor antagonists, NSAIDs, muscarinic antagonists, gastroprotective agents (within the previous 7 days). 3. Patients with history of pathological conditions of the intestine including inflammatory bowel disease/malabsorption syndromes/gastrointestinal malignancy/gastric or intestinal surgery including vagotomy/ Barrett's esophagus/ scleroderma. 4. Patients showing alarm features (unintentional weight loss, persistent vomiting, dysphagia, haematemesis, melaena, fever, jaundice, or anaemia), or serious concomitant disease. 5. Patients with signs of significant/massive GI bleeding. 6. Patients who are unsuitable for pharmacotherapy e.g., with GI perforation or pyloric stenosis/esophageal stricture/intestinal obstruction. 7. The presence of major hematological, renal, cardiac, pulmonary, or hepatic abnormalities. 8. Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study. 9. Patients who had previously been included or who had participated in any other clinical trial within the last 2 month. 10. Patients who are drug or alcohol abusers or suffering from any other condition associated with poor compliance. 11. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with more than or equal to 50% improvement in baseline symptom severity. 2. Proportion of patients reporting a maximal allowable score of 20 on the VAS Scale for the clinical symptoms evaluated. 3. Proportion of patients reporting a change in the ulcer stage based on the endoscopic examinations. 4. Reduction in the size of the ulcer. 5. Resolution of other endoscopic findings of gastritis and/or peptic ulcers defined as a score of 2 or less for erosions. Timepoint: baseline, day 14 and day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sustained clinical symptom relief defined as the absence of the clinical symptom evaluated in the previous 7 days. 2. Cure of peptic ulcer based on endoscopic findings. 3. Cure of gastritis and/or peptic ulcers based on the endoscopic examinations. 4. Patient and Investigator assessment of efficacy and tolerance. Timepoint: 1. Day 7. 2. Day 28. 3. Day 28. 4. Day 28. | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Ltd.
Outcome results
None listed