Natural History of Non-steroidal Anti-inflammatory Drug and Non-Helicobacter Pylori in Bleeding Peptic 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. Identifier: NCT00153712
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 17, 2017
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong

Brief Summary:
The aim of this study is to study the natural history of the ulcer healing while on proton pump inhibitors (PPI) and the ulcer recurrence without acid suppression therapy of Non-steroidal Anti-inflammatory Drugs (NSAID), non-Helicobacter pylori (HP) bleeding ulcer patients.

Condition or disease
Peptic Ulcer

Detailed Description:
Non-steroidal Anti-inflammatory Drugs (NSAID), Non-Helicobacter pylori (HP) bleeding peptic ulcers are relatively common in the West (11%-44%). It is uncommon in Hong Kong (4%). Significant number of these patients with non-NSAID, non-Hp bleeding ulcers had co-morbid illness and many had life-threatening conditions. Our recent study showed that there is an increasing incidence of non-steroidal anti-inflammatory drugs (NSAID), non-Helicobacter pylori (Hp) bleeding peptic ulcers. There is no datum on the natural course of these patients and this is our aim to have this observational study.

Study Type : Observational
Actual Enrollment : 391 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study to Study the Natural History and Ulcer Recurrence Without Acid Suppression of Non-NSAID, Non-HP Bleeding Peptic Ulcer Patients
Study Start Date : August 2002
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Non NSAID non-Hp
Patient of history of peptic ulcer bleeding with Hp-ve and without prior history of taking NSAID or Aspirin within 30 days
Helicobacter pylori +ve
Patient with Hp+ve at peptic ulcer bleeding

Primary Outcome Measures :
  1. Recurrent ulcer bleeding [ Time Frame: During the observation period ]
    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 :
  1. All-cause mortality [ Time Frame: During the observation period ]
    The secondary endpoint is recurrent lower gastrointestinal (GI) bleeding, which was defined as recurrent overt bleeding (melena or hematochezia without an upper GI source) or a drop in hemoglobin >2 g/dL, without an upper GI source or other non-GI causes of anemia. We excluded hemorrhoidal bleeding and colorectal cancer as lower GI outcomes.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All peptic ulcer bleeding patients

Inclusion Criteria:

  • Patient has non-NSAID (non-steroidal anti-inflammatory drugs), non-Helicobacter pylori bleeding peptic ulcer
  • Age > 18 years old
  • Informed consent

Exclusion Criteria:

  • Concommitant use of high dose steroid or warfarin
  • New start on non-steroidal anti-inflammatory drugs or aspirin or COX2 inhibitors
  • Renal failure (serum creatinine > 200umol/l)
  • Previous gastric surgery
  • Oesophagitis, esophageal varices
  • Terminal illness or malignancy

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 identifier (NCT number): NCT00153712

China, Hong Kong
Endoscopy Center, Prince of Wales Hospital
Shatin, Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Francis K Chan, MD Chinese University of Hong Kong

Responsible Party: Francis KL Chan, Professor, Chinese University of Hong Kong Identifier: NCT00153712     History of Changes
Other Study ID Numbers: NNH Study
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by Francis KL Chan, Chinese University of Hong Kong:
Non-Hp Bleeding Peptic Ulcer

Additional relevant MeSH terms:
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents