PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers

Phase 4

Completed

• Conditions: Peptic Ulcer
• Interventions: Drug: Famotidine; Drug: Lansoprazole

• Registration Number: NCT01180179
• Lead Sponsor: Chinese University of Hong Kong

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%.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Famotidine 40mg once daily	Famotidine	Famotidine 40mg once daily
Lansoprazole 30mg once daily	Lansoprazole	Lansoprazole 30mg once daily

Primary Outcome Measures

Name	Time	Method
Recurrent ulcer bleeding	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.

Secondary Outcome Measures

Name	Time	Method
Recurrent ulcer detected by endoscopy at 24-month	at the 24th month of follow-up	Recurrent ulcer detected by endoscopy at 24-month, with or without clinical symptoms.

Trial Locations

Locations (1)

Endoscopy Center, Prince of Wales Hospital, Shatin; 🇨🇳 Hong Kong, China