Trial | NCT00731601  Report issue

Title

Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
Phase 4 Study of Intravenous Proton Pump Inhibitor in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pantoprazole ...

  • Study Participants

    120
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.
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 Started
May 31
2008
Primary Completion
Mar 31
2009
Study Completion
Apr 30
2009
Last Update
Apr 07
2009
Estimate

Drug pantoprazole

pantoprazole 40 mg/q6h IV infusion for three days

  • Other names: pantoloc

Drug pantoprazole

pantoprazole 8 mg/h IV infusion for three days

  • Other names: pantoloc

1 Experimental

pantoprazole 40mg/q6h IV infusion for three days

2 Active Comparator

pantoprazole 8mg/h for three days

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.
No Results Posted