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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00153712
Other study ID # NNH Study
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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