Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding (PPI)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- The primary end point was recurrent bleeding before discharge and within 14 days. [ Time Frame: About one year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
pantoprazole 40mg/q6h IV infusion for three days
pantoprazole 40 mg/q6h IV infusion for three days
Other Name: pantoloc
Active Comparator: 2
pantoprazole 8mg/h for three days
pantoprazole 8 mg/h IV infusion for three days
Other Name: pantoloc
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731601
|Lotung Poh-Ai hospital|
|Yilan, Taiwan, 26514|
|Principal Investigator:||Hwai-jeng Lin, M.D.||Lotung Poh-Ai Hospital|