PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
- Recurrent ulcer bleeding [ Time Frame: 24 months ] [ Designated as safety issue: No ]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.
- Recurrent ulcer detected by endoscopy at 24-month [ Time Frame: at the 24th month of follow-up ] [ Designated as safety issue: No ]Recurrent ulcer detected by endoscopy at 24-month, with or without clinical symptoms.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Lansoprazole 30mg once daily
Lansoprazole 30mg once daily
30mg once daily
Other Name: Lansoprazole
Active Comparator: Famotidine 40mg once daily
Famotidine 40mg once daily
40mg once daily
Other Name: Famotidine
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%.
|Contact: Kim W Au, Msc||+852 2632 email@example.com|
|China, Hong Kong|
|Endoscopy Center, Prince of Wales Hospital||Recruiting|
|Shatin, Hong Kong, China|
|Contact: Francis K Chan, MD firstname.lastname@example.org|
|Contact: Kim W Au, MSc email@example.com|
|Principal Investigator:||Francis K Chan, MD||Chinese University of Hong Kong|