PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
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ClinicalTrials.gov Identifier: NCT01180179 |
Recruitment Status :
Completed
First Posted : August 12, 2010
Last Update Posted : August 1, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peptic Ulcer | Drug: Lansoprazole Drug: Famotidine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 228 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Prevention of Recurrent Idiopathic Gastroduodenal Ulcer Bleeding: a Double-blind Randomized Trial |
Actual Study Start Date : | June 2010 |
Actual Primary Completion Date : | May 2019 |
Actual Study Completion Date : | May 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Lansoprazole 30mg once daily
Lansoprazole 30mg once daily
|
Drug: Lansoprazole
30mg once daily |
Active Comparator: Famotidine 40mg once daily
Famotidine 40mg once daily
|
Drug: Famotidine
40mg once daily |
- Recurrent ulcer bleeding [ Time Frame: 24 months ]
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.
- Recurrent ulcer detected by endoscopy at 24-month [ Time Frame: at the 24th month of follow-up ]Recurrent ulcer detected by endoscopy at 24-month, with or without clinical symptoms.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180179
China | |
Endoscopy Center, Prince of Wales Hospital, Shatin | |
Hong Kong, China |
Principal Investigator: | Grace L Wong, MD | Chinese University of Hong Kong |
Responsible Party: | Francis KL Chan, Professor, Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT01180179 |
Other Study ID Numbers: |
NNH_RCT |
First Posted: | August 12, 2010 Key Record Dates |
Last Update Posted: | August 1, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
H. pylori-negative idiopathic peptic ulcers Recurrent ulcer bleeding |
Peptic Ulcer Ulcer Hemorrhage Pathologic Processes Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Lansoprazole Dexlansoprazole |
Famotidine Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Histamine H2 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Physiological Effects of Drugs |