Comparison of Oral Rabeprazole vs. iv Omeprazole in Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding

NCT00861640 | Unknown Phase 4 DMC

• 1 other identifier: KMUH-IRB-970338
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nonvariceal Upper Gastrointestinal Bleeding

Keywords

rabeprazole; omeprazole; upper gastrointestinal bleeding

Outcome Measures

Primary Outcomes (1)

• 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.

  one year later

Study Arms (2)

Intravenous Omeprazole

EXPERIMENTAL

100 cases of Intravenous Omeprazole

Drug: Intravenous Omeprazole

Oral Rabeprazole

EXPERIMENTAL

100 cases of oral rabeprazole

Drug: Oral Rabeprazole

Interventions

Intravenous Omeprazole DRUG

Intravenous Omeprazole 1amp qd (every day)

Also known as: iv losec

Intravenous Omeprazole

Oral Rabeprazole DRUG

Oral Rabeprazole 1 bid

Also known as: pariet

Oral Rabeprazole

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• moderate to mild upper gastrointestinal peptic ulcer bleeding

You may not qualify if:

• shock
• liver cirrhosis
• uremia
• severe UGI bleeding

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead
• Kaohsiung Medical University: collaborator

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Omeprazole; Rabeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chien-Yu Lu, MD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Yu Lu, MD

CONTACT

886-7-3121101; dr820188@pchome.com.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 13, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 15, 2009

Record last verified: 2009-07

Locations

TW (1)