Peptic Ulcer Clinical Trial
Official title:
Prevention of Recurrent Idiopathic Gastroduodenal Ulcer Bleeding: a Double-blind Randomized Trial
NCT number | NCT01180179 |
Other study ID # | NNH_RCT |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 2010 |
Est. completion date | May 2019 |
Verified date | July 2019 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 228 |
Est. completion date | May 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Endoscopy Center, Prince of Wales Hospital, Shatin | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrent ulcer bleeding | According to prespecified criteria — hematemesis or melena documented by the admitting physician, or a decrease in the hemoglobin level of at least 2 g/dL, with ulcers or bleeding erosions confirmed on endoscopy. A prespecified interim-analysis is performed on the primary endpoint when all patients have been randomised and have completed the 12 months follow-up. The interim-analysis is performed by an independent statistician, blinded for the treatment allocation. The statistician will report to the independent data and safety monitoring committee (DSMC). The DSMC will have unblinded access to all data and will discuss the results of the interim-analysis with the steering committee in a joint meeting. The steering committee decides on the continuation of the trial and will report to the central ethics committee. The Peto approach is used: the trial will be ended using symmetric stopping boundaries at P < 0.001. |
24 months | |
Secondary | Recurrent ulcer detected by endoscopy at 24-month | Recurrent ulcer detected by endoscopy at 24-month, with or without clinical symptoms. | at the 24th month of follow-up |
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