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

Peptic Ulcer Clinical Trial

Official title:

Prevention of Recurrent Idiopathic Gastroduodenal Ulcer Bleeding: a Double-blind Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180179
• Other study ID #: NNH_RCT
• Status: Completed
• Phase: Phase 4
• Start date: June 2010
• Est. completion date: May 2019

Study information

• Verified date: July 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hemorrhage
• Peptic Ulcer
• Ulcer

Intervention

Drug:
• Lansoprazole
30mg once daily
• Famotidine
40mg once daily

Locations

Country	Name	City	State
China	Endoscopy Center, Prince of Wales Hospital, Shatin	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

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