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

This study has been terminated.
(Terminated before the complete enrollment due to slow enrollment)
Sponsor:
Collaborator:
Janssen Korea, Ltd., Korea
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT00838682
First received: February 5, 2009
Last updated: August 31, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Peptic Ulcer Hemorrhage
 Drug: omeprazole sodium IV
Drug: Rabeprazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Rebleeding Within 3 Days [ Time Frame: day 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rebleeding After 3 Days [ Time Frame: 6wk ] [ Designated as safety issue: Yes ]
    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.

  • Surgery [ Time Frame: 6wk ] [ Designated as safety issue: Yes ]
    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.

  • Death [ Time Frame: 6wk ] [ Designated as safety issue: Yes ]

Enrollment: 106
Study Start Date: April 2006
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Losec 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.

  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
Bucheon St. Mary's 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: Hiun-Suk Chae, Professor The Catholic University of Korea
  More Information

No publications provided

Responsible Party: HiunSuk Chae, The Catholic University of Korea College of Medicine
ClinicalTrials.gov Identifier: NCT00838682     History of Changes
Other Study ID Numbers: RAB-KOR-18
Study First Received: February 5, 2009
Results First Received: August 2, 2010
Last Updated: August 31, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by The Catholic University of Korea:
peptic ulcer bleeding
rabeprazole
proton pump inhibitor

Additional relevant MeSH terms:
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
 Gastrointestinal Hemorrhage
Omeprazole
Rabeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013