Back to resultsPPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
Primary Purpose
Peptic Ulcer
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lansoprazole
Famotidine
Sponsored by
About this trial
This is an interventional prevention trial for Peptic Ulcer focused on measuring H. pylori-negative idiopathic peptic ulcers, Recurrent ulcer bleeding
Eligibility Criteria
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
- 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
Sites / Locations
- Endoscopy Center, Prince of Wales Hospital, Shatin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lansoprazole 30mg once daily
Famotidine 40mg once daily
Arm Description
Lansoprazole 30mg once daily
Famotidine 40mg once daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Recurrent ulcer detected by endoscopy at 24-month
Recurrent ulcer detected by endoscopy at 24-month, with or without clinical symptoms.
Full Information
NCT ID
NCT01180179
First Posted
August 3, 2010
Last Updated
July 31, 2019
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01180179
Brief Title
PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
Official Title
Prevention of Recurrent Idiopathic Gastroduodenal Ulcer Bleeding: a Double-blind Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 2010 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 history of H. pylori-negative idiopathic peptic ulcers.
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 has been an increasing trend of peptic ulcer disease with unknown cause (idiopathic ulcer) worldwide since the last decade. Studies in North America found that idiopathic ulcers accounted for 11% and 44% of all peptic ulcers. A meta-analysis of 7 US trials found that 20% of patients with H. pylori-associated ulcers had recurrent ulcers within 6 months, despite successful cure of H. pylori infection and no reported use of NSAIDs. In a pooled analysis of 6 clinical trials with a total of 2900 patients, 27% of duodenal ulcers were not associated with NSAID use or H. pylori infection. The emerging problem of H. pylori-negative idiopathic peptic ulcers is not only limited to western countries. Previously, H. pylori-negative idiopathic peptic ulcers accounted for less than 5% of peptic ulcers in Asia. A recent Korean study reported that the proportion of peptic ulcers not associated with H. pylori infection or NSAID use was over 20%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer
Keywords
H. pylori-negative idiopathic peptic ulcers, Recurrent ulcer bleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lansoprazole 30mg once daily
Arm Type
Active Comparator
Arm Description
Lansoprazole 30mg once daily
Arm Title
Famotidine 40mg once daily
Arm Type
Active Comparator
Arm Description
Famotidine 40mg once daily
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Intervention Description
30mg once daily
Intervention Type
Drug
Intervention Name(s)
Famotidine
Intervention Description
40mg once daily
Primary Outcome Measure Information:
Title
Recurrent ulcer bleeding
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Recurrent ulcer detected by endoscopy at 24-month
Description
Recurrent ulcer detected by endoscopy at 24-month, with or without clinical symptoms.
Time Frame
at the 24th month of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace L Wong, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Center, Prince of Wales Hospital, Shatin
City
Hong Kong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31229990
Citation
Wong GLH, Lau LHS, Ching JYL, Tse YK, Ling RHY, Wong VWS, Chiu PWY, Lau JYW, Chan FKL. Prevention of recurrent idiopathic gastroduodenal ulcer bleeding: a double-blind, randomised trial. Gut. 2020 Apr;69(4):652-657. doi: 10.1136/gutjnl-2019-318715. Epub 2019 Jun 22.
Results Reference
derived
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PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
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