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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

September 8, 2005
February 28, 2013
August 2002
July 2009   (final data collection date for primary outcome measure)
Recurrent ulcer bleeding [ Time Frame: During the observation period ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00153712 on ClinicalTrials.gov Archive Site
All-cause mortality [ Time Frame: During the observation period ] [ Designated as safety issue: No ]
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Natural History of Non-steroidal Anti-inflammatory Drug and Non-Helicobacter Pylori in Bleeding Peptic Ulcers
A Prospective Cohort Study to Study the Natural History and Ulcer Recurrence Without Acid Suppression of Non-NSAID, Non-HP Bleeding Peptic Ulcer Patients

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

All peptic ulcer bleeding patients
Peptic Ulcer
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
391
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00153712
NNH Study
No
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
February 2013

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