Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
PPI
Phase 4 Study of Intravenous Proton Pump Inhibitor in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 7, 2008
CompletedFirst Posted
Study publicly available on registry
August 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedApril 7, 2009
April 1, 2009
10 months
August 7, 2008
April 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary end point was recurrent bleeding before discharge and within 14 days.
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.
about one year
Study Arms (2)
1
EXPERIMENTALpantoprazole 40mg/q6h IV infusion for three days
2
ACTIVE COMPARATORpantoprazole 8mg/h for three days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lotung Poh-Ai hospital
Yilan, 26514, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hwai-jeng Lin, M.D.
Lotung Poh-Ai Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 7, 2008
First Posted
August 11, 2008
Study Start
May 1, 2008
Primary Completion
March 1, 2009
Study Completion
April 1, 2009
Last Updated
April 7, 2009
Record last verified: 2009-04