NCT00153712

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
391

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

6.9 years

First QC Date

September 8, 2005

Last Update Submit

August 15, 2017

Conditions

Peptic Ulcer

Keywords

Non-NSAIDNon-Hp Bleeding Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • All-cause mortality

    During the observation period

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All peptic ulcer bleeding patients

You may qualify if:

  • Patient has non-NSAID (non-steroidal anti-inflammatory drugs), non-Helicobacter pylori bleeding peptic ulcer
  • Age \> 18 years old
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Shatin, Hong Kong, China

Location

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Officials

  • Francis K Chan, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2002

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 17, 2017

Record last verified: 2017-08

Locations

CN(1)