Peptic Ulcer HemorrhagePhase 3NCT00164931
A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer
A Phase 3 study testing Intravenous omeprazole infusion and Scheduled second endoscopy in people with Peptic Ulcer Hemorrhage, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- Intravenous omeprazole infusion and Scheduled second endoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Oct 2003to not given
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all consecutive patients admitted for peptic ulcer bleeding (including bleeding anastomotic ulcers) with emergency endoscopy done in 24 hours after admission with Forrest type Ia, Ib, and IIa, IIb
- age 15 - 90 years
- Written consent available
Who cannot join
- ulcer bleeding not controlled in first endoscopy
- Bleeding from malignant ulcer or tumor
- Bleeding from Dieulafoy lesion/ angiodysplasia
- Bleeding from injection sclerotherapy ulcer
- Patient with ASA category 5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of Prospective Randomized Trial Comparing Adjunctive High Dose Omeprazole Infusion Against Scheduled Second Endoscopy in the Prevention of Peptic Ulcer Rebleeding After Therapeutic Endoscopy
A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy.
Read the detailed description
We have previously performed a prospective randomized controlled trial on the effect of scheduled second endoscopy upon peptic ulcer rebleeding. We found that the rate of recurrent bleeding was significantly reduced from 13.8% to 5% with a scheduled second endoscopy and appropriate therapy performed within 24 hours after initial hemostasis.
When we look at the studies in the literature employing proton pump inhibitors (PPI) infusion after primary endoscopic therapy, we found that there was also a significant reduction in the rate of rebleeding, the number of operation performed and the transfusion requirement.
Controversy exists regarding the optimal strategy to minimize recurrent peptic ulcer bleeding after successful endoscopic hemostasis. A recent cost-effective analysis on various strategies showed that selective scheduled second endoscopy strategy was probably the most effective and least expensive to prevent recurrent peptic ulcer bleeding.
We conduct a randomized trial on the cost-effectiveness of using omeprazole infusion vs scheduled second endoscopy on the management of bleeding peptic ulcers.
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- Intravenous omeprazole infusion, Scheduled second endoscopy
- Keywords
- Peptic ulcer hemorrhage, Omeprazole, Scheduled second endoscopy
- 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.
Intravenous omeprazole infusionDrug
Scheduled second endoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent bleeding within 30 days after initial endoscopy defined as -
Clinical criteria (anyone of the below)
1. Haemetmesis or fresh blood from Ryles tube
2. Fresh melena with shock (systolic blood pressure < 100mmHg or pulse >100/min) or drop in Hb > 2g/dl
3. Haemoglobin drop for more than 4 g/dl in 24 hours before 2nd therapeutic endoscopy
4. Blood transfusion of > 4 unit in 24 hours to stabilize Hb level or vital signs
AND Endoscopic criteria of Forrest I a, b or II a, b
Secondary outcomes (4)
1. The rate of surgery
2. Mortality
3. Length of Hospital stay
4. Transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2003
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 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Philip WY Chiu, MBChB, FRCSEd, Principal investigator, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong KongHenry KM Joeng, MBBS, Principal investigator, Department of Surgery, United Christian Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164931
- Sponsor's protocol ID
- UCHCE03-43-SURG5
- Status last verified
- Sep 2005
- First submitted
- 11 Sep 2005
- Last updated
- 10 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Prospective Randomized Trial Comparing Adjunctive High Dose Omeprazole Infusion Against Scheduled Second Endoscopy in the Prevention of Peptic Ulcer Rebleeding After Therapeutic Endoscopy
- ClinicalTrials.gov ID
- NCT00164931
- Acronym / sponsor ID
- UCHCE03-43-SURG5
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- Peptic ulcer hemorrhage, Omeprazole, Scheduled second endoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2003
- First posted
- 14 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.
A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy.
Detailed description
We have previously performed a prospective randomized controlled trial on the effect of scheduled second endoscopy upon peptic ulcer rebleeding. We found that the rate of recurrent bleeding was significantly reduced from 13.8% to 5% with a scheduled second endoscopy and appropriate therapy performed within 24 hours after initial hemostasis.
When we look at the studies in the literature employing proton pump inhibitors (PPI) infusion after primary endoscopic therapy, we found that there was also a significant reduction in the rate of rebleeding, the number of operation performed and the transfusion requirement.
Controversy exists regarding the optimal strategy to minimize recurrent peptic ulcer bleeding after successful endoscopic hemostasis. A recent cost-effective analysis on various strategies showed that selective scheduled second endoscopy strategy was probably the most effective and least expensive to prevent recurrent peptic ulcer bleeding.
We conduct a randomized trial on the cost-effectiveness of using omeprazole infusion vs scheduled second endoscopy on the management of bleeding peptic ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all consecutive patients admitted for peptic ulcer bleeding (including bleeding anastomotic ulcers) with emergency endoscopy done in 24 hours after admission with Forrest type Ia, Ib, and IIa, IIb
- age 15 - 90 years
- Written consent available
Key exclusion criteria (5 listed)
- ulcer bleeding not controlled in first endoscopy
- Bleeding from malignant ulcer or tumor
- Bleeding from Dieulafoy lesion/ angiodysplasia
- Bleeding from injection sclerotherapy ulcer
- Patient with ASA category 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous omeprazole infusion | Drug | – |
| Scheduled second endoscopy | Procedure or surgery | – |
Primary outcome
Recurrent bleeding within 30 days after initial endoscopy defined as -
Clinical criteria (anyone of the below)
1. Haemetmesis or fresh blood from Ryles tube
2. Fresh melena with shock (systolic blood pressure < 100mmHg or pulse >100/min) or drop in Hb > 2g/dl
3. Haemoglobin drop for more than 4 g/dl in 24 hours before 2nd therapeutic endoscopy
4. Blood transfusion of > 4 unit in 24 hours to stabilize Hb level or vital signs
AND Endoscopic criteria of Forrest I a, b or II a, b
4 secondary outcomes
1. The rate of surgery
2. Mortality
3. Length of Hospital stay
4. Transfusion
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 10 Jun 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.
Philip WY Chiu, MBChB, FRCSEd principal investigator
Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Henry KM Joeng, MBBS principal investigator
Department of Surgery, United Christian Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous omeprazole infusion and Scheduled second endoscopy in people with Peptic Ulcer Hemorrhage, 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 5 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 10 Jun 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 bleeding within 30 days after initial endoscopy defined as -. The study lists 7 primary outcomes in all. 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 10 Jun 2011.