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Sponsored by: |
Lotung Poh-Ai Hospital |
Information provided by: | Lotung Poh-Ai Hospital |
ClinicalTrials.gov Identifier: | NCT00731601 |
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.
Condition | Intervention | Phase |
Peptic Ulcer Hemorrhage |
Drug: pantoprazole |
Phase IV |
MedlinePlus related topics: | Peptic Ulcer |
Drug Information available for: | Pantoprazole Pantoprazole Sodium |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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 |
Estimated Enrollment: | 120 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
pantoprazole 40mg/q6h IV infusion for three days
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Drug: pantoprazole
pantoprazole 40 mg/q6h IV infusion for three days
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2: Active Comparator
pantoprazole 8mg/h for three days
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Drug: pantoprazole
pantoprazole 8 mg/h IV infusion for three days
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hwai-jeng Lin, M.D. | 886-39543131 ext 5400 | hjlin@mail.pohai.org.tw |
Contact: Yun-chen chien | 886-39543131 ext 5411 | 909010@mail.pohai.org.tw |
Taiwan | |||||
Lotung Poh-Ai hospital | Recruiting | ||||
Yilan, Taiwan, 26514 | |||||
Contact: Hwai-jeng Lin, m.d. 88639543131 ext 5400 hjlin@mail.pohai.org.tw | |||||
Principal Investigator: Hwai-jeng Lin, M.D. |
Lotung Poh-Ai Hospital |
Principal Investigator: | Hwai-jeng Lin, M.D. | Lotung Poh-Ai Hospital |
Responsible Party: | Lotung Poh-Ai Hospital ( Lin, Hwai-jeng, M.D. FACG ) |
Study ID Numbers: | LotungPAH |
First Received: | August 7, 2008 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00731601 |
Health Authority: | Taiwan: Department of Health |
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