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

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.

Study Overview

• Status: Terminated
• Conditions: Peptic Ulcer Hemorrhage
• Intervention / Treatment: Drug: Rabeprazole; Drug: omeprazole sodium IV

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyungkido
    • Bucheon, Kyungkido, Korea, Republic of
      • Bucheon St. Mary's Hospital
    • Uijeongbu, Kyungkido, Korea, Republic of
      • Uijeongbu St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Pariet
Active Comparator: 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.	Drug: 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.; Other Names: Losec IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rebleeding Within 3 Days	day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rebleeding After 3 Days	Rebleeding after 3 days was assessed by checking the patients from day 3 to discharge and bleeding event or regular follow-up after discharge to week 6.	6wk
Surgery	This sencodary endpoint "surgery" is the operation for bleeding control of peptic ulcer bleeding such as gastric or duodenal primary closure, and subtotal gastrectomy with/without vagotomy.	6wk
Death		6wk

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Units of Blood Transfusion	In order to compare the total amount of blood transfusion, mean units of blood transfusion was used.	day 3
Duration of Hospital Stay		6wk

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Collaborators: Janssen Korea, Ltd., Korea
• Investigators: Principal Investigator: Hiun-Suk Chae, Professor, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: February 5, 2009
• First Submitted That Met QC Criteria: February 5, 2009
• First Posted (Estimate): February 6, 2009

Study Record Updates

• Last Update Posted (Estimate): September 24, 2010
• Last Update Submitted That Met QC Criteria: August 31, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: proton pump inhibitor; rabeprazole; peptic ulcer bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Gastrointestinal Hemorrhage; Ulcer; Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole; Omeprazole
• Other Study ID Numbers: RAB-KOR-18