Effect of High-Dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers - Full Text View

Sponsors and Collaborators:	The Catholic University of Korea Janssen Korea, Ltd., Korea
Information provided by:	The Catholic University of Korea
ClinicalTrials.gov Identifier:	NCT00838682

Purpose

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

Condition	Intervention	Phase
Peptic Ulcer Hemorrhage	Drug: omeprazole sodium IV Drug: Rabeprazole	Phase IV

MedlinePlus related topics: Endoscopy Peptic Ulcer

Drug Information available for: Omeprazole Omeprazole magnesium Omeprazole sodium E 3810 Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of High-Dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:

Signs of bleeding(recurrent bleeding) [ Time Frame: day1,3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

observation measures and clinical laboratory tests [ Time Frame: 6weeks ] [ Designated as safety issue: Yes ]

Enrollment:	106
Study Start Date:	February 2005
Estimated Study Completion Date:	March 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
rabeprazole sodium: Experimental 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. From Day 4, both groups will receive oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
Omeprazole: Active Comparator Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, both groups will receive 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. 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. From Day 4, both groups will receive oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Arms

Assigned Interventions

rabeprazole sodium: Experimental

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. From Day 4, both groups will receive oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Omeprazole: Active Comparator

Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, both groups will receive 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.

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. From Day 4, both groups will receive oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Detailed Description:

0.1 % of hospitalized patients are attributed to upper gastrointestinal (GI) bleeding every year in the U.S. and Europe, among which peptic ulcer is the most common cause of upper GI 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 PPI 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 PPIs 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 PPI with that of oral Rabeprazole after endoscopic treatment of bleeding peptic ulcers. Therefore, in this study, after administering a high-dose intravenous PPI 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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838682

Locations

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

Sponsors and Collaborators

The Catholic University of Korea

Janssen Korea, Ltd., Korea

Investigators

Principal Investigator:

HiunSuk Chae, Professor

The Catholic University of Korea

More Information

No publications provided

Responsible Party:	The Catholic University of Korea College of Medicine ( HiunSuk Chae )
Study ID Numbers:	RAB-KOR-18
Study First Received:	February 5, 2009
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00838682 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by The Catholic University of Korea:

peptic ulcer bleeding
rabeprazole
proton pump inhibitor

Study placed in the following topic categories:

Gastrointestinal Diseases
Ulcer
Gastrointestinal Hemorrhage
Omeprazole
Hemorrhage
Intestinal Diseases
Recurrence

Digestive System Diseases
Stomach Diseases
Proton Pump Inhibitors
Peptic Ulcer Hemorrhage
Peptic Ulcer
Duodenal Diseases
Rabeprazole

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Ulcer
Gastrointestinal Agents
Gastrointestinal Hemorrhage
Omeprazole
Enzyme Inhibitors
Hemorrhage
Intestinal Diseases
Pharmacologic Actions

Pathologic Processes
Digestive System Diseases
Stomach Diseases
Therapeutic Uses
Peptic Ulcer Hemorrhage
Anti-Ulcer Agents
Peptic Ulcer
Duodenal Diseases
Rabeprazole

ClinicalTrials.gov processed this record on May 06, 2009