Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers

NCT ID: NCT00838682

Last Updated: 2010-09-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-03-31

Brief Summary

This study is conducted to compare and evaluate the effect of administering a high-dose intravenous proton pump inhibitors or high-dose oral Rabeprazole in preventing recurrent bleeding after the endoscopic treatment of bleeding peptic ulcers.

Detailed Description

0.1 % of hospitalized patients are attributed to upper gastrointestinal bleeding every year in the U.S. and Europe, among which peptic ulcer is the most common cause of upper gastrointestinal bleeding. Endoscopic hemostasis procedure in the management of bleeding due to peptic ulcers was safe as well as effective and lowered recurrent bleeding, surgery and mortality. Endoscopic treatment is widely used as an effective and safe method but it has disadvantages including the need for the endoscopy specialist and the likelihood of developing the complications such as perforation or recurrent bleeding although they rarely occur. Thus, less invasive medical treatments with fewer side effects have been continuously studied and among them, gastric acid inhibitors have been studied the most.Acid and pepsin inhibit platelet aggregation, activation of blood coagulation system, and fibrinogen polymerization. Blood clots already formed are digested by pepsin and the activity of pepsin is closely related to intragastric pH level. Therefore, it is known that an elevated intragastric pH facilitates hemostasis process, induces hemostasis by stabilizing hematoma and prevents recurrent bleeding. To suffice these conditions, it is reported that a potent gastric acid inhibitor is needed to maintain intragastric pH of 6 or higher.

For the treatment of bleeding peptic ulcers, the intravenous administration of a high-dose proton pump inhibitor after the initial endoscopic treatment has shown a decline in the frequency of recurrent bleeding as well as surgery. Recent studies reported that the use of oral proton pump inhibitor was effective under certain circumstances in the treatment of bleeding peptic ulcers. However, to date, no study has been conducted to compare the effect of a high-dose intravenous proton pump inhibitor with that of oral Rabeprazole after endoscopic treatment of bleeding peptic ulcers. Therefore, in this study, after administering a high-dose intravenous proton pump inhibitor or high-dose oral Rabeprazole in preventing recurrent bleeding following endoscopic treatment of bleeding peptic ulcers, we are going to compare the rate of recurrent bleeding between the two groups as well as to compare and evaluate the surgery rate, mortality rate and the number of days of hospital stay.

Conditions

Peptic Ulcer Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rabeprazole sodium

Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Group Type: EXPERIMENTAL

Rabeprazole

Intervention Type: DRUG

Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Omeprazole

Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Group Type: ACTIVE_COMPARATOR

omeprazole sodium IV

Intervention Type: DRUG

Intravenous Omeprazole (brand name: Losec® injection 40 mg) 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Interventions

omeprazole sodium IV

Intravenous Omeprazole (brand name: Losec® injection 40 mg) 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Intervention Type: DRUG

Rabeprazole

Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Intervention Type: DRUG

Other Intervention Names

Losec IV; Pariet

Eligibility Criteria

Inclusion Criteria

• Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization
• patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy

Exclusion Criteria

• Patients who refuse endoscopic procedure
• Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation)
• Pregnancy
• Patients with serious concurrent diseases such as malignant tumors or end-stage diseases
• History of previous gastrectomy or vagotomy
• Known hypersensitivity to proton pump inhibitors
• Elderly patients
• Epilepsy

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: collaborator

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

The Catholic University of Korea College of Medicine

Principal Investigators

Hiun-Suk Chae, Professor

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

Bucheon St. Mary's Hospital

Bucheon-si, Kyungkido, South Korea

Uijeongbu St.Mary's Hospital

Uijeongbu-si, Kyungkido, South Korea

Countries

South Korea

Other Identifiers

RAB-KOR-18

Identifier Type: -

Identifier Source: org_study_id