Peptic Ulcer HemorrhagePUBNCT01241266
China Survey of Peptic Ulcer Bleeding
An observational study of Peptic Ulcer Hemorrhage, run by AstraZeneca at 31 sites in China.
Trial summary
This will be a multicenter prospective observational study carried out in China. The investigators will collect data in a pre-specified Case Report Form. Main data from each patient will include demographics, endoscopy classification, and both endoscopy and pharmacological treatments received by patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- How many people
- 1,044 participants
- Where
- 31 sitesChina
- Study dates
- Nov 2010to Jul 2011
- 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: Hospitalized Patients
Who may be able to join
- Female and/or male aged 18 years and above
- Admitted to the hospital with an overt upper GI bleeding (hematemesis/coffee ground vomiting, melena, hematochezia and other clinical or laboratory evidence of acute blood loss from the upper GI tract)
- Endoscopy demonstrated peptic ulcer bleeding (Forrest I-III)
Who cannot join
- If participating in any clinical trial, the subject cannot take part in this study.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
China31 sites
Research Site
Beijing, Beijing Municipality
Research Site
Changchun, Jilin
Research Site
Changsha, Hunan
Research Site
Chengdu, Sichuan
Research Site
Chongqing, Chongqing Municipality
Research Site
Fuyang, Zhejiang
Research Site
Fuzhou, Fujian
Research Site
Guangzhou, Guangdong
Research Site
Haerbin, Heilongjiang
Research Site
Hangzhou, Zhejiang
Research Site
Hefei, Anhui
Research Site
Hohhot, Neimeng
Research Site
Jiangyin, Jiangsu
Research Site
Jinan, Shandong
Research Site
Jinhua, Zhejiang
Research Site
Kunming, Yunnan
Research Site
Lanzhou, Gansu
Research Site
Nanchang, Jiangxi
Research Site
Nanjing, Jiangsu
Research Site
Nantong, Jiangsu
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoning
Research Site
Shenzhen, Guangdong
Research Site
Taiyuan, Shanxi
Research Site
Tianjin, Tianjin Municipality
Research Site
Ürümqi, Xinjiang
Research Site
Wenzhou, Zhejiang
Research Site
Wuhan, Hubei
Research Site
Xiamen, Fujian
Research Site
Xian, Shanxi
Research Site
Yangquan, Shanxi
About this study
This will be a multicenter prospective observational study carried out in China. The investigators will collect data in a pre-specified Case Report Form. Main data from each patient will include demographics, endoscopy classification, and both endoscopy and pharmacological treatments received by patients. Data from each patient will be prospectively collected from the day the patient is diagnosed as peptic ulcer bleeding by endoscopy and receives endoscopy treatment if the investigator thinks it is needed and up to 30 days afterwards. The proportion of peptic ulcer bleeding patients who are at high risk is the primary outcome variable. High risk is defined as the patients with endoscopy Forrest classification Ia to IIb. The rate and type of endoscopic treatment, the rate of successful endoscopy treatment, the re-bleeding rate and the endoscopic re-treatment rate in high risk peptic ulcer bleeding patients will be collected. The surgery rate and mortality rate in high risk and overall patient population will be calculated.
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- Peptic Ulcer Bleeding, high risk, None-Interventional Study, he proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb)
- Medical subject headings
- Peptic Ulcer Hemorrhage
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 |
|---|---|---|
| 1 | Target subject population are the consecutive patients hospitalized due to peptic ulcer bleeding. Subjects should be: ≥18 years; admitted to the hospital with an overt upper GI bleed (hematemesis/coffee ground vomiting, melena, hematochezia and other clin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb).
Measured: 1 day
Secondary outcomes (3)
The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb) and receiving endoscopic treatment
Measured: 1 day
The proportion of patients receiving endoscopic treatments by type of endoscopic treatmentendoscopic treatment
Measured: 5 day
The clinically significant re-bleeding rate of high risk (Forrest Ia-IIb) peptic ulcer bleeding patients treated with or without PPI or H2RA, at 3, 5 and 30 days after successful endoscopy treatment.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer HemorrhageStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,044 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Atkin, Study director, Astrazeneca China R&DZhaoshen Li, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241266
- Sponsor's protocol ID
- NIS-GCN-DUM-2010/1
- Other IDs
- D961DL00006
- Acronym
- PUB
- Status last verified
- Dec 2011
- First submitted
- 4 Nov 2010
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Survey of Peptic Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT01241266
- Acronym / sponsor ID
- PUB / NIS-GCN-DUM-2010/1
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- Peptic Ulcer Bleeding, high risk, None-Interventional Study, he proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,044 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Nov 2010 (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.
This will be a multicenter prospective observational study carried out in China. The investigators will collect data in a pre-specified Case Report Form. Main data from each patient will include demographics, endoscopy classification, and both endoscopy and pharmacological treatments received by patients. Data from each patient will be prospectively collected from the day the patient is diagnosed as peptic ulcer bleeding by endoscopy and receives endoscopy treatment if the investigator thinks it is needed and up to 30 days afterwards. The proportion of peptic ulcer bleeding patients who are at high risk is the primary outcome variable. High risk is defined as the patients with endoscopy Forrest classification Ia to IIb. The rate and type of endoscopic treatment, the rate of successful endoscopy treatment, the re-bleeding rate and the endoscopic re-treatment rate in high risk peptic ulcer bleeding patients will be collected. The surgery rate and mortality rate in high risk and overall patient population will be calculated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Target subject population are the consecutive patients hospitalized due to peptic ulcer bleeding. Subjects should be: ≥18 years; admitted to the hospital with an overt upper GI bleed (hematemesis/coffee ground vomiting, melena, hematochezia and other clin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized Patients
Key inclusion criteria (3 listed)
- Female and/or male aged 18 years and above
- Admitted to the hospital with an overt upper GI bleeding (hematemesis/coffee ground vomiting, melena, hematochezia and other clinical or laboratory evidence of acute blood loss from the upper GI tract)
- Endoscopy demonstrated peptic ulcer bleeding (Forrest I-III)
Key exclusion criteria (1 listed)
- If participating in any clinical trial, the subject cannot take part in this study.
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
The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb).
Time frame: 1 day
3 secondary outcomes
The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb) and receiving endoscopic treatment
Time frame: 1 day
The proportion of patients receiving endoscopic treatments by type of endoscopic treatmentendoscopic treatment
Time frame: 5 day
The clinically significant re-bleeding rate of high risk (Forrest Ia-IIb) peptic ulcer bleeding patients treated with or without PPI or H2RA, at 3, 5 and 30 days after successful endoscopy treatment.
Time frame: 30 days
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 30 Dec 2011.
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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.
Karen Atkin study director
Astrazeneca China R&D
Zhaoshen Li principal investigator
Changhai Hospital
31 sites 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 Hemorrhage, run by AstraZeneca at 31 sites 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 1 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 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites 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?
The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb). (time frame: 1 day). 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 30 Dec 2011.