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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:
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

August 3, 2010
August 10, 2015
June 2010
December 2017   (final data collection date for primary outcome measure)
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.
Same as current
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
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
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Recruiting
228
May 2018
December 2017   (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
Both
18 Years and older   (Adult, Senior)
No
Contact: Kim W Au, Msc +852 2632 2640 kimau@surgery.cuhk.edu.hk
Contact: Au
China
 
NCT01180179
NNH_RCT
Yes
Not Provided
Not Provided
Francis KL Chan, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Francis K Chan, MD Chinese University of Hong Kong
Chinese University of Hong Kong
August 2015

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