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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180179
First Posted: August 12, 2010
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong
August 3, 2010
August 12, 2010
August 17, 2017
June 2010
December 2018   (Final data collection date for primary outcome measure)
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.

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.
Complete list of historical versions of study NCT01180179 on ClinicalTrials.gov Archive Site
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.
Recurrent ulcer detected by end-of-study endoscopy [ Time Frame: at the 24th month of follow-up ]
Recurrent ulcer detected by end-of-study endoscopy, with or without clinical symptoms.
Not Provided
Not Provided
 
PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
Prevention of Recurrent Idiopathic Gastroduodenal Ulcer Bleeding: a Double-blind Randomized Trial
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.
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%.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Peptic Ulcer
  • Drug: Lansoprazole
    30mg once daily
  • Drug: Famotidine
    40mg once daily
  • Active Comparator: Lansoprazole 30mg once daily
    Lansoprazole 30mg once daily
    Intervention: Drug: Lansoprazole
  • Active Comparator: Famotidine 40mg once daily
    Famotidine 40mg once daily
    Intervention: Drug: Famotidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
228
May 2019
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01180179
NNH_RCT
Yes
Not Provided
Plan to Share IPD: No
Francis KL Chan, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Grace L Wong, MD Chinese University of Hong Kong
Chinese University of Hong Kong
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP