Peptic Ulcer BleedinglowdosePPINCT04407832
Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy
A study testing heat probe or hemoclip in people with Peptic Ulcer Bleeding, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
The investigators used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Peptic Ulcer Bleeding
- What is being tested?
- heat probe or hemoclip
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Sep 2013
- Phase
- Interventional
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with peptic ulcer bleeding with active bleeding or nonbleeding visible (initial Hb<10, shock, or coffee grounds or blood in stomach)
Who cannot join
- age >90y/o
- pregnant woman
- allergic to esomeprazole
- unwilling to enter this study
- bleeding tendency
- severe co-morbid illness, including cancer, hepatic failure, renal failure,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding
The investigators used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.
The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.
Read the detailed description
A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients receiving intravenous Proton Pump Inhibitor (PPI）and is now recommended as the first hemostatic modality for these patients. In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, including two consensus statements and two meta-analysis. To sustain a high intragastric pH, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. However, in one recent published metaanalysis found that low dose PPI may be as effective as high dose PPI in preventing further bleeding in high-risk patients. Therefore, one double blind study is needed clarify this puzzle.
We used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.
The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.
- Conditions
- Peptic Ulcer Bleeding
- Being tested
- heat probe or hemoclip
- Keywords
- hemostasis, heat probe, hemoclip, rebleeding
- 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.
heat probe or hemoclipDevice
Also called Olympus co.
for hemostasis
heat probe or hemoclipDevice
Also called Olympus co.
for hemostasis
| Study group | Role | What they receive |
|---|---|---|
| low dose PPI | Active comparator | 40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months Receives: Device: heat probe or hemoclip |
| high dose PPI | Active comparator | 40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months Receives: Device: heat probe or hemoclip |
What is being measured
The primary outcome is the main question the study is designed to answer.
further bleeding
Number of participants with rebleeding within 14 days
Measured: 14 days
Secondary outcomes (4)
hospital stay
hospital stay in day
Measured: 30 days
need of blood transfusion
number of participants need of blood transufion
Measured: 30 days
surgical intervention
number of participants need surgical intervention to manage bleeding
Measured: 30 days
mortality
number of participants death
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 posted29 May 2020
- Study startAug 2011
- Primary completionJul 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer BleedingStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Hospital, Dalin Tzu Chi General Hospital
- Responsible party
- Sponsor
- Investigators
- Hwai-jeng Lin, M.D., Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407832
- Sponsor's protocol ID
- lowdosePPI
- Acronym
- lowdosePPI
- Status last verified
- May 2020
- First submitted
- 4 Aug 2011
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT04407832
- Acronym / sponsor ID
- lowdosePPI / lowdosePPI
- Conditions
- Peptic Ulcer Bleeding
- Keywords
- hemostasis, heat probe, hemoclip, rebleeding
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University Hospital, Dalin Tzu Chi General Hospital
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 29 May 2020 (actual)
- 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 investigators used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.
The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.
Detailed description
A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients receiving intravenous Proton Pump Inhibitor (PPI）and is now recommended as the first hemostatic modality for these patients. In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, including two consensus statements and two meta-analysis. To sustain a high intragastric pH, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. However, in one recent published metaanalysis found that low dose PPI may be as effective as high dose PPI in preventing further bleeding in high-risk patients. Therefore, one double blind study is needed clarify this puzzle.
We used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.
The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose PPI | Active comparator | Device: heat probe or hemoclip40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months |
| high dose PPI | Active comparator | Device: heat probe or hemoclip40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with peptic ulcer bleeding with active bleeding or nonbleeding visible (initial Hb<10, shock, or coffee grounds or blood in stomach)
Key exclusion criteria (6 listed)
- age >90y/o
- pregnant woman
- allergic to esomeprazole
- unwilling to enter this study
- bleeding tendency
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 |
|---|---|---|
| heat probe or hemoclipAlso: Olympus co.for hemostasis | Device | low dose PPI |
| heat probe or hemoclipAlso: Olympus co.for hemostasis | Device | high dose PPI |
Primary outcome
further bleeding
Time frame: 14 days
Number of participants with rebleeding within 14 days
4 secondary outcomes
hospital stay
Time frame: 30 days
need of blood transfusion
Time frame: 30 days
surgical intervention
Time frame: 30 days
mortality
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
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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.
Hwai-jeng Lin, M.D. principal investigator
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heat probe or hemoclip in people with Peptic Ulcer Bleeding, run by Changhua Christian Hospital at 1 site in Taiwan.
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 1 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: withdrawn, as of the sponsor's last update on 29 May 2020. 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 Taiwan. 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 was withdrawn before enrolling participants, so there are no results.
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?
further bleeding (time frame: 14 days). 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 29 May 2020.