PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers (NCT01180179) | Clinical Trial Compass
CompletedPhase 4
PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
China228 participantsStarted 2010-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. A history of H. pylori-negative idiopathic peptic ulcers, defined as
✓. No exposure to aspirin, NSAIDs or drugs of unknown nature including traditional Chinese medicine within the 4 weeks before hospitalization;
✓. 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
✓. No other causes of ulceration identified.
✓. Endoscopically confirmed ulcer healing
✓. Age \>18 years old
✓. Informed consent
Exclusion criteria
✕. Concomitant steroid or anticoagulant
✕. Concomitant use of NSAIDs, aspirin or COX2 inhibitors
✕. Previous gastric surgery
✕. Requirement of maintenance PPI (e.g. reflux oesophagitis)
✕. Advanced comorbidity (defined as ASA 4 or above) or active malignancy
✕. Subjects who are pregnant or lactating, or is intending to become pregnant before, during, or within 1 month after participating in this study