PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
Information source: Chinese University of Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peptic Ulcer
Intervention: Lansoprazole (Drug); Famotidine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Chinese University of Hong Kong Official(s) and/or principal investigator(s): Francis K Chan, MD, Principal Investigator, Affiliation: Chinese University of Hong Kong
Overall contact: Kim W Au, Msc, Phone: +852 2632 2640, Email: kimau@surgery.cuhk.edu.hk
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.
Clinical Details
Official title: Proton-Pump Inhibitor Versus Histamine-2 Receptor Antagonist on the Rebleeding Rate in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers: A Double-Blind Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Recurrent ulcer bleeding
Secondary outcome: Recurrent ulcer detected by endoscopy at 24-month
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%.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Kim W Au, Msc, Phone: +852 2632 2640, Email: kimau@surgery.cuhk.edu.hk
Endoscopy Center, Prince of Wales Hospital, Shatin, Hong Kong, China; Recruiting Francis K Chan, MD, Email: fklchan@cuhk.edu.hk Kim W Au, MSc, Email: kimau@surgery.cuhk.edu.hk
Additional Information
Starting date: June 2010
Last updated: August 10, 2015
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