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

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.
 
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

Tracking Information
First Submitted Date  ICMJE August 3, 2010
First Posted Date  ICMJE August 12, 2010
Last Update Posted Date August 1, 2019
Actual Study Start Date  ICMJE June 2010
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2012)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
Official Title  ICMJE Prevention of Recurrent Idiopathic Gastroduodenal Ulcer Bleeding: a Double-blind Randomized Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Peptic Ulcer
Intervention  ICMJE
  • Drug: Lansoprazole
    30mg once daily
  • Drug: Famotidine
    40mg once daily
Study Arms  ICMJE
  • 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
Publications * Wong GLH, Lau LHS, Ching JYL, Tse YK, Ling RHY, Wong VWS, Chiu PWY, Lau JYW, Chan FKL. Prevention of recurrent idiopathic gastroduodenal ulcer bleeding: a double-blind, randomised trial. Gut. 2020 Apr;69(4):652-657. doi: 10.1136/gutjnl-2019-318715. Epub 2019 Jun 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2013)
228
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2010)
170
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01180179
Other Study ID Numbers  ICMJE NNH_RCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Francis KL Chan, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Grace L Wong, MD Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date July 2019

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