PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to compare the efficacy of a proton pump inhibitor (lansoprazole) and a histamine-2 receptor antagonist (famotidine) in preventing recurrent ulcer bleeding in patients with a history of H. pylori-negative idiopathic peptic ulcers.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Dexlansoprazole; Famotidine; Lansoprazole

Criteria

Inclusion Criteria:

1. A history of H. pylori-negative idiopathic peptic ulcers, defined as

1. No exposure to aspirin, NSAIDs or drugs of unknown nature including traditional Chinese medicine within the 4 weeks before hospitalization;

2. Biopsies taken during endoscopy must be negative for both the urease test and histology for H. pylori in the absence of acid suppressive therapy; and

3. No other causes of ulceration identified.

2. Endoscopically confirmed ulcer healing

3. Age >18 years old

4. Informed consent

Exclusion Criteria:

1. Concomitant steroid or anticoagulant

2. Concomitant use of NSAIDs, aspirin or COX2 inhibitors

3. Previous gastric surgery

4. Requirement of maintenance PPI (e.g. reflux oesophagitis)

5. Advanced comorbidity (defined as ASA 4 or above) or active malignancy

6. Subjects who are pregnant or lactating, or is intending to become pregnant before, during, or within 1 month after participating in this study

7. Subjects who have known hypersensitivity or allergies to any component of lansoprazole or famotidine.

8. Subject who has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition