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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 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: February 28, 2013
Last verified: February 2013
  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: February 2015
Estimated Primary Completion Date: October 2014 (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
Other Name: Lansoprazole
Active Comparator: Famotidine 40mg once daily
Famotidine 40mg once daily
Drug: Famotidine
40mg once daily
Other Name: Famotidine

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
Genders Eligible for Study:   Both
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
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

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

No publications provided

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: February 28, 2013
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:
Hemorrhage
Peptic Ulcer
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Famotidine
Lansoprazole
Dexlansoprazole
Histamine H2 Antagonists
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014