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

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ClinicalTrials.gov Identifier: NCT01180179
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Drug: Lansoprazole Drug: Famotidine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Recurrent Idiopathic Gastroduodenal Ulcer Bleeding: a Double-blind Randomized Trial
Actual Study Start Date : June 2010
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Recurrent ulcer bleeding [ Time Frame: 24 months ]

    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.



Secondary Outcome Measures :
  1. Recurrent ulcer detected by endoscopy at 24-month [ Time Frame: at the 24th month of follow-up ]
    Recurrent ulcer detected by endoscopy at 24-month, with or without clinical symptoms.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180179


Locations
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China
Endoscopy Center, Prince of Wales Hospital, Shatin
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Grace L Wong, MD Chinese University of Hong Kong
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Francis KL Chan, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01180179    
Other Study ID Numbers: NNH_RCT
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Francis KL Chan, Chinese University of Hong Kong:
H. pylori-negative idiopathic peptic ulcers
Recurrent ulcer bleeding
Additional relevant MeSH terms:
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Peptic Ulcer
Ulcer
Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Lansoprazole
Dexlansoprazole
 Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs