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Completed

NCT Number: NCT00153712

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

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.

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Key information

Conditions

Peptic Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Endoscopy Center, Prince of Wales Hospital

Shatin, Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Sep 12, 2005
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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