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Natural History of Non-steroidal Anti-inflammatory Drug and Non-Helicobacter Pylori in Bleeding Peptic Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00153712
First received: September 8, 2005
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Peptic Ulcer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer
U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Recurrent ulcer bleeding [ Time Frame: During the observation period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: During the observation period ] [ Designated as safety issue: No ]

Enrollment: 391
Study Start Date: August 2002
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All peptic ulcer bleeding patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153712

Locations
China, Hong Kong
Endoscopy Center, Prince of Wales Hospital
Shatin, Hong Kong, China
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: NCT00153712     History of Changes
Other Study ID Numbers: NNH Study
Study First Received: September 8, 2005
Last Updated: February 28, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Non-NSAID
Non-Hp Bleeding Peptic Ulcer

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

ClinicalTrials.gov processed this record on May 16, 2013