Status:
COMPLETED
PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Peptic Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Peptic ulcer disease used to be caused by a bacterial infection (Helicobacter pylori) in the stomach or the use of certain painkillers (nonsteroidal anti-inflammatory drugs or NSAIDs). However, there ...
Eligibility Criteria
Inclusion
- 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
- 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
- Subjects who have known hypersensitivity or allergies to any component of lansoprazole or famotidine.
- Subject who has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT01180179
Start Date
June 1 2010
End Date
May 1 2019
Last Update
August 1 2019
Active Locations (1)
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1
Endoscopy Center, Prince of Wales Hospital, Shatin
Hong Kong, China