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CompletedNCT00731601PPIUpdated Apr 7, 2009

Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding

A Phase 4 interventional study of pantoprazole and pantoprazole in Peptic Ulcer Hemorrhage, sponsored by Lotung Poh-Ai Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-04-07.

Sponsored by Lotung Poh-Ai Hospital · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Peptic Ulcer Hemorrhage

Keywords

  • shock
  • peptic ulcer bleeding
  • rebleeding
03

In context

Peptic Ulcer

193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.

This study's enrollment of 120 is below the median of 150 across 142 interventional studies indexed under Peptic Ulcer.

Browse Peptic Ulcer studies →

Lead sponsor

Lotung Poh-Ai Hospital is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    1

    pantoprazole 40mg/q6h IV infusion for three days

    Drug: pantoprazole

  • Active comparator
    2

    pantoprazole 8mg/h for three days

    Drug: pantoprazole

Interventions

  • Drugpantoprazole

    pantoprazole 40 mg/q6h IV infusion for three days

    Also known as: pantoloc

  • Drugpantoprazole

    pantoprazole 8 mg/h IV infusion for three days

    Also known as: pantoloc

06

What researchers measure

Primary outcomes

  1. The primary end point was recurrent bleeding before discharge and within 14 days.

    Time frame: About one year

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Lotung Poh-Ai hospital
    Yilan, 26514, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00731601
Lead sponsor
Lotung Poh-Ai Hospital
First posted
Aug 11, 2008
Start date
May 2008
Primary completion
Mar 2009
Completion
Apr 2009
Last update
Apr 7, 2009

Study contacts

Hwai-jeng Lin, M.D.
principal investigator · Lotung Poh-Ai Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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