Nonvariceal Upper Gastrointestinal Bleeding Clinical Trial
Official title:
The Comparison of Oral Rabeprazole vs. Intravenous Omeprazole in the Treatment of Patients With Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding
Introduction: Proton pump inhibitor (PPI) is the drug of choice used in patients with
non-variceal upper gastrointestinal tract bleeding (UGIB). Intravenous (IV) PPI is more
commonly used than oral form when overt bleeding occurs. Previous study has revealed that
oral rabeprazole and IV omeprazole achieved similar intragastric pH elevation. It's probable
that oral form and IV PPI provide equal efficacy in treating mild to moderate UGIB patients.
Aim: This study aims to compare the effect of three-day oral rabeprazole and iv omeprazole
on bleeding control in patients with mild to moderate non-variceal UGIB.
Patients and methods: All patients presented with black to tarry stool passage or
hematemesis and visited our ER will be evaluated to recruit into this study. They will
receive regular vital sign monitoring, laboratory study and nasogastric tube insertion with
gastric fluid aspiration. Esophagogastroendoscopy and hemostatic procedure if need will be
performed within 12 hours. Those confirmed to have non-variceal UGIB, stable vital signs and
agree to participate into this study will be randomized into two groups receiving either
oral rabeprazole (20mg bid) or iv omeprazole (40mg qd) for three days. The presence of
recurrent bleeding within three days, in-hospital complication and duration of hospital stay
will be recorded and analyzed.
Expected results: At the end of this study, we will be able to determine whether patients
treated with oral rabeprazole and iv omeprazole have similar re-bleeding or complication
rates and hospitalization days.
Proton pump inhibitor (PPI) is the drug of choice used in patients with non-variceal upper
gastrointestinal tract bleeding (UGIB). Intravenous (IV) PPI is more commonly used than oral
form when overt bleeding occurs. Previous study has revealed that oral rabeprazole and IV
omeprazole achieved similar intragastric pH elevation. It's probable that oral form and IV
PPI provide equal efficacy in treating mild to moderate UGIB patients.
This study aims to compare the effect of three-day oral rabeprazole and iv omeprazole on
bleeding control in patients with mild to moderate non-variceal UGIB. The expected numbers
of intravenous and oral PPI were 100 respectively.
All patients presented with black to tarry stool passage or hematemesis and visited our ER
will be evaluated to recruit into this study. They will receive regular vital sign
monitoring, laboratory study and nasogastric tube insertion with gastric fluid aspiration.
Esophagogastroendoscopy and hemostatic procedure if need will be performed within 12 hours.
Those confirmed to have non-variceal UGIB, stable vital signs and agree to participate into
this study will be randomized into two groups receiving either oral rabeprazole (20mg bid)
or iv omeprazole (40mg qd) for three days. The presence of recurrent bleeding within three
days, in-hospital complication and duration of hospital stay will be recorded and analyzed.
At the end of this study, we will be able to determine whether patients treated with oral
rabeprazole and iv pantoprazole have similar re-bleeding or complication rates and
hospitalization days.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04124588 -
Effectiveness of 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding
|
N/A |