Peptic Ulcer HemorrhagePhase 4PPINCT00731601
Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
A Phase 4 study testing pantoprazole in people with Peptic Ulcer Hemorrhage, run by Lotung Poh-Ai Hospital at 1 site in Taiwan.
Trial summary
A large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- pantoprazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2008to Apr 2009
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were accepted for endoscopic therapy if a peptic ulcer with active bleeding, a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base was observed within 24 hours of hospital admission.
Who cannot join
- If patients were pregnant
- Did not obtain initial hemostasis with endoscopic injection of epinephrine
- Did not give written informed consent
- Had bleeding tendency (platelet count < 50×109/L, serum prothrombin < 30% of normal, or were taking anticoagulants), uremia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Intravenous Proton Pump Inhibitor in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial
A large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding.
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 with bleeding peptic ulcers 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, two consensus statements and two meta-analysis. In our previous experience, we used omeprazole 160 mg /day infusion instead of 8 mg/h in these patients and obtained a good result .
The objectives of this study are to assess the outcomes of two different regimens of high dose of intravenous pantoprazole after endoscopic therapy in patients with peptic ulcer bleeding.
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- pantoprazole
- Keywords
- shock, peptic ulcer bleeding, rebleeding
- Medical subject headings
- Peptic Ulcer Hemorrhage, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pantoprazoleDrug
Also called pantoloc
pantoprazole 40 mg/q6h IV infusion for three days
pantoprazoleDrug
Also called pantoloc
pantoprazole 8 mg/h IV infusion for three days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | pantoprazole 40mg/q6h IV infusion for three days Receives: Drug: pantoprazole |
| 2 | Active comparator | pantoprazole 8mg/h for three days Receives: Drug: pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point was recurrent bleeding before discharge and within 14 days.
Measured: About one year
Secondary outcomes (1)
At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared.
Measured: about one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionApr 2009
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.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lotung Poh-Ai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hwai-jeng Lin, M.D., Principal investigator, Lotung Poh-Ai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731601
- Sponsor's protocol ID
- LotungPAH
- Acronym
- PPI
- Status last verified
- Apr 2009
- First submitted
- 7 Aug 2008
- Last updated
- 7 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Intravenous Proton Pump Inhibitor in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT00731601
- Acronym / sponsor ID
- PPI / LotungPAH
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- shock, peptic ulcer bleeding, rebleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Lotung Poh-Ai HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 11 Aug 2008 (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 large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding.
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 with bleeding peptic ulcers 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, two consensus statements and two meta-analysis. In our previous experience, we used omeprazole 160 mg /day infusion instead of 8 mg/h in these patients and obtained a good result .
The objectives of this study are to assess the outcomes of two different regimens of high dose of intravenous pantoprazole after endoscopic therapy in patients with peptic ulcer bleeding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: pantoprazolepantoprazole 40mg/q6h IV infusion for three days |
| 2 | Active comparator | Drug: pantoprazolepantoprazole 8mg/h for three days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were accepted for endoscopic therapy if a peptic ulcer with active bleeding, a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base was observed within 24 hours of hospital admission.
Key exclusion criteria (4 listed)
- If patients were pregnant
- Did not obtain initial hemostasis with endoscopic injection of epinephrine
- Did not give written informed consent
- Had bleeding tendency (platelet count < 50×109/L, serum prothrombin < 30% of normal, or were taking anticoagulants), uremia.
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 |
|---|---|---|
| pantoprazoleAlso: pantolocpantoprazole 40 mg/q6h IV infusion for three days | Drug | 1 |
| pantoprazoleAlso: pantolocpantoprazole 8 mg/h IV infusion for three days | Drug | 2 |
Primary outcome
The primary end point was recurrent bleeding before discharge and within 14 days.
Time frame: About one year
1 secondary outcome
At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared.
Time frame: about one year
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 7 Apr 2009.
Related trials for Peptic Ulcer Hemorrhage
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RecruitingPhase 2
Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers
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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
Lotung Poh-Ai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pantoprazole in people with Peptic Ulcer Hemorrhage, run by Lotung Poh-Ai 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 4 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 7 Apr 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The primary end point was recurrent bleeding before discharge and within 14 days. (time frame: About one year). 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 7 Apr 2009.