Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding (PPI)
Primary Purpose
Peptic Ulcer Hemorrhage
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
pantoprazole
pantoprazole
Sponsored by
About this trial
This is an interventional prevention trial for Peptic Ulcer Hemorrhage focused on measuring shock, peptic ulcer bleeding, rebleeding
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Lotung Poh-Ai hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
pantoprazole 40mg/q6h IV infusion for three days
pantoprazole 8mg/h for three days
Outcomes
Primary Outcome Measures
The primary end point was recurrent bleeding before discharge and within 14 days.
Secondary Outcome Measures
At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00731601
Brief Title
Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
Acronym
PPI
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lotung Poh-Ai Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Hemorrhage
Keywords
shock, peptic ulcer bleeding, rebleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
pantoprazole 40mg/q6h IV infusion for three days
Arm Title
2
Arm Type
Active Comparator
Arm Description
pantoprazole 8mg/h for three days
Intervention Type
Drug
Intervention Name(s)
pantoprazole
Other Intervention Name(s)
pantoloc
Intervention Description
pantoprazole 40 mg/q6h IV infusion for three days
Intervention Type
Drug
Intervention Name(s)
pantoprazole
Other Intervention Name(s)
pantoloc
Intervention Description
pantoprazole 8 mg/h IV infusion for three days
Primary Outcome Measure Information:
Title
The primary end point was recurrent bleeding before discharge and within 14 days.
Time Frame
About one year
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hwai-jeng Lin, M.D.
Organizational Affiliation
Lotung Poh-Ai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lotung Poh-Ai hospital
City
Yilan
ZIP/Postal Code
26514
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
We'll reach out to this number within 24 hrs