Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding

Peptic Ulcer Hemorrhage Clinical Trial

— PPI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731601
• Other study ID #: LotungPAH
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2008
• Last updated: April 6, 2009
• Start date: May 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Lotung Poh-Ai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Drug:
• pantoprazole
pantoprazole 40 mg/q6h IV infusion for three days
• pantoprazole
pantoprazole 8 mg/h IV infusion for three days

Locations

Country	Name	City	State
Taiwan	Lotung Poh-Ai hospital	Yilan

Sponsors (1)

Lead Sponsor	Collaborator
Lotung Poh-Ai Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point was recurrent bleeding before discharge and within 14 days.		About one year	No
Secondary	At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared.		about one year	No