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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00731601

Acronym

PPI

Enrollment

120

Registered

2008-08-11

Start date

2008-05-31

Completion date

2009-04-30

Last updated

2009-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer Hemorrhage

Keywords

shock, peptic ulcer bleeding, rebleeding

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.

Interventions

DRUGpantoprazole

pantoprazole 40 mg/q6h IV infusion for three days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The primary end point was recurrent bleeding before discharge and within 14 days.	About one year

Secondary

Measure	Time frame
At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared.	about one year

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026