PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2015 by Chinese University of Hong Kong
Sponsor:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01180179
First received: August 3, 2010
Last updated: August 10, 2015
Last verified: August 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Peptic Ulcer |
Drug: Lansoprazole Drug: Famotidine |
Phase 4 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Chinese University of Hong Kong:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 228 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | May 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Lansoprazole 30mg once daily
Lansoprazole 30mg once daily
|
Drug: Lansoprazole
30mg once daily
|
|
Active Comparator: Famotidine 40mg once daily
Famotidine 40mg once daily
|
Drug: Famotidine
40mg once daily
|
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
A history of H. pylori-negative idiopathic peptic ulcers, defined as
- No exposure to aspirin, NSAIDs or drugs of unknown nature including traditional Chinese medicine within the 4 weeks before hospitalization;
- 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
- No other causes of ulceration identified.
- Endoscopically confirmed ulcer healing
- Age >18 years old
- Informed consent
Exclusion Criteria:
- Concomitant steroid or anticoagulant
- Concomitant use of NSAIDs, aspirin or COX2 inhibitors
- Previous gastric surgery
- Requirement of maintenance PPI (e.g. reflux oesophagitis)
- Advanced comorbidity (defined as ASA 4 or above) or active malignancy
- Subjects who are pregnant or lactating, or is intending to become pregnant before, during, or within 1 month after participating in this study
- Subjects who have known hypersensitivity or allergies to any component of lansoprazole or famotidine.
- Subject who has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180179
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180179
Contacts
| Contact: Kim W Au, Msc | +852 2632 2640 | kimau@surgery.cuhk.edu.hk | |
| Contact: Au |
Locations
| China, Hong Kong | |
| Endoscopy Center, Prince of Wales Hospital | Recruiting |
| Shatin, Hong Kong, China | |
| Contact: Francis K Chan, MD fklchan@cuhk.edu.hk | |
| Contact: Kim W Au, MSc kimau@surgery.cuhk.edu.hk | |
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
| Principal Investigator: | Francis K Chan, MD | Chinese University of Hong Kong |
More Information
| Responsible Party: | Francis KL Chan, Professor, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01180179 History of Changes |
| Other Study ID Numbers: | NNH_RCT |
| Study First Received: | August 3, 2010 |
| Last Updated: | August 10, 2015 |
| Health Authority: | Hong Kong: Department of Health |
Keywords provided by Chinese University of Hong Kong:
|
H. pylori-negative idiopathic peptic ulcers Recurrent ulcer bleeding |
Additional relevant MeSH terms:
|
Ulcer Hemorrhage Peptic Ulcer Pathologic Processes Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Lansoprazole Dexlansoprazole |
Famotidine Proton Pump Inhibitors Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Histamine H2 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016