Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding (PPI)
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|ClinicalTrials.gov Identifier: NCT00731601|
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : April 7, 2009
|Condition or disease||Intervention/treatment||Phase|
|Peptic Ulcer Hemorrhage||Drug: pantoprazole||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||April 2009|
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
- The primary end point was recurrent bleeding before discharge and within 14 days. [ Time Frame: About one year ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731601
|Lotung Poh-Ai hospital|
|Yilan, Taiwan, 26514|
|Principal Investigator:||Hwai-jeng Lin, M.D.||Lotung Poh-Ai Hospital|