Peptic UlcerNCT00153712
Natural History of Non-steroidal Anti-inflammatory Drug and Non-Helicobacter Pylori in Bleeding Peptic Ulcers
An observational study of Peptic Ulcer, run by Chinese University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer
- How many people
- 391 participants
- Where
- 1 siteChina
- Study dates
- Aug 2002to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All peptic ulcer bleeding patients
Who may be able to join
- Patient has non-NSAID (non-steroidal anti-inflammatory drugs), non-Helicobacter pylori bleeding peptic ulcer
- Age > 18 years old
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Peptic Ulcer
- Keywords
- Non-NSAID, Non-Hp Bleeding Peptic Ulcer
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the observation period
Secondary outcomes (1)
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.
Measured: During the observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francis KL Chan, Chinese University of Hong Kong
- Investigators
- Francis K Chan, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153712
- Sponsor's protocol ID
- NNH Study
- Status last verified
- Aug 2017
- First submitted
- 8 Sep 2005
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00153712
- Acronym / sponsor ID
- NNH Study
- Conditions
- Peptic Ulcer
- Keywords
- Non-NSAID, Non-Hp Bleeding Peptic Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All peptic ulcer bleeding patients
Key inclusion criteria (3 listed)
- Patient has non-NSAID (non-steroidal anti-inflammatory drugs), non-Helicobacter pylori bleeding peptic ulcer
- Age > 18 years old
- Informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
All-cause mortality
Time frame: During the observation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis K Chan, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peptic Ulcer, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent ulcer bleeding (time frame: During the observation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.