Ignite Creation Date:
2024-05-05 @ 10:45 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01180179
Status:
COMPLETED
Last Update Posted:
2019-08-01
First Post:
2010-08-03
Brief Title:
PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Prevention of Recurrent Idiopathic Gastroduodenal Ulcer Bleeding a Double-blind Randomized Trial
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None