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

Peptic Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153712
• Other study ID #: NNH Study
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: August 15, 2017
• Start date: August 2002
• Est. completion date: July 2009

Study information

• Verified date: August 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Locations

Country	Name	City	State
China	Endoscopy Center, Prince of Wales Hospital	Shatin	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent ulcer bleeding	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.	During the observation period
Secondary	All-cause mortality	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.	During the observation period